Pain, AcutePhase 4NCT03187080
Enhanced Recovery Strategies in Elective Breast Surgery
A Phase 4 study testing Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Enhanced recovery after breast surgery (ERABS) strategies and Paravertebral block using local anesthetic in people with Pain, Acute and Nausea, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Nausea, Vomiting, Postoperative
- What is being tested?
- Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Enhanced recovery after breast surgery (ERABS) strategies and Paravertebral block using local anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 15 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age equal to and greater than 18 years.
- Medically cleared to undergo elective breast surgery (including associated anesthesia) at UW Transformations Surgery Center or Madison Surgery Center (MSC).
- Undergoing bilateral breast augmentation or bilateral breast reduction by the PI (Dr. Venkat Rao).
Who cannot join
- Minors or under the age of 18
- Pregnant or breast feeding women
- Incarcerated women
- Males
- Individuals unable to give consent due to another condition such as impaired decision-making capacity.
- Women who take opioid pain medications on a regular basis prior to surgery.
Show all 14Show fewer
- Women with a history of opioid abuse and/or dependence.
- Women who, based on anesthesiologist discretion, are not candidates for paravertebral block.
- Women with BMI >35
- Women with a diagnosis of obstructive sleep apnea who are noncompliant with their treatment (e.g. CPAP use).
- Women with a history of bleeding disorders precluding safe paravertebral block.
- Women on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist.
- Women with a history of infection at the site of paravertebral block.
- Women not medically cleared for surgery at Transformations or MSC and thus would not be undergoing surgery at Transformations or MSC. This would include women with sepsis/bacteremia, significant valvular disorders or heart conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Madison
Madison, Wisconsin, 53792
About this study
Official title: Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation
Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide.
The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. The investigators will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.
Read the detailed description
Bilateral breast reduction and bilateral breast augmentation are both routine plastic surgery procedures commonly performed on an outpatient basis. While patient satisfaction following these procedures is high, postoperative pain management can be challenging, resulting in decreased patient satisfaction, delayed recovery including delayed return to work and daily activities, increased opioid pain medication requirements and occasionally unplanned hospital admissions, surgical complications, and increased cost of care.
PVB is a common procedure used for analgesia in breast surgery in combination with multimodal perioperative pain regimens, though its use has not been formally studied in a prospective fashion. To date, no prospective, randomized, blinded study has been performed to evaluate the efficacy of PVB on perioperative pain management in this patient population.
The overarching goal of this study is to evaluate the safety and efficacy of PVB alone, as well as in conjunction with a global set of perioperative enhanced recovery strategies in elective breast surgery. The investigators hypothesize that the use of such strategies will improve the patient experience of breast reduction and augmentation beyond the current standard of care.
There are four serial aims of this study. The overarching goal of the study is to prospectively assess the use of PVB as an adjunct for postoperative pain control both alone and in the setting of related ERABS strategies in elective breast surgery (both breast reduction and breast augmentation, two of the most common non-oncologic breast operations performed in an ambulatory setting). The methodologies used to assess postoperative pain, the set of collective ERABS strategies, the potential risks and benefits of study participation, and the inclusion/exclusion criteria will be the same in the groups studying breast reduction and those studying breast augmentation.
Following completion of all 4 groups, the investigators will be able to assess the impact of PVB alone as well as the impact of ERABS strategies in both breast reduction and breast augmentation.
The primary aim in all four groups in this study is to evaluate postoperative pain scores in patients receiving either paravertebral block or ERABS strategies compared to patients who do not receive these interventions. Additional outcomes include use of analgesic and antiemetic medication, development of PONV, time to discharge, patients' assessment of quality of recovery as determined by a validated survey and overall patient satisfaction.
Group 1: To prospectively determine the effect of PVB on perioperative pain and postoperative recovery following breast reduction. Patient-reported pain assessments (including a numeric rating scale) will be used to evaluate the primary endpoint (pain scores on postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this study, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the Post Anesthesia Care Unit (PACU), average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, the occurrence of unplanned hospital admission will be evaluated, PONV assessed, overall satisfaction, patients' assessment of quality of recovery as determined by a validated survey, and complications documented. This data will be obtained through review of medical records, surveys, and postoperative diaries.
Patients electing to undergo breast reduction will be invited to participate in the study at their preoperative visit. All patients choosing to take part in the study will be consented prior to their procedure. The study participants will be randomized to one of two arms within each Group using block randomization. Details of the allocated group will be written on a piece of paper and placed inside sealed, opaque, and sequentially numbered, envelopes. Block randomization will be performed using a computer-generated number list and an Excel spreadsheet template. Block randomization will ensure equal numbers of subjects in each group. Either the anesthesiologist or the surgical team will open the envelope when the patient presents to UW Transformations Surgery Center or Madison Surgery Center (MSC) the day of surgery. The subject will be randomized to receive either (a) standard postoperative nausea and pain control as well as a sham superficial injection of normal saline or (b) PVB in addition to standard postoperative nausea and pain control. PVB and sham superficial injections of normal saline will be performed by a trained anesthesiology provider and will be performed in the routine manner. Surgery will take place in the usual fashion and participants will receive standard of care for pain and nausea control.
Following surgery, patients will be assessed for postoperative pain, nausea and vomiting. Assessment for postoperative pain will consist of a validated pain score survey administered prior to transfer to phase II postoperatively, on POD1, and at their one-week postoperative visit. Participants will also be asked to record, using a postoperative diary/log, when they take postoperative analgesics and antiemetics, which medications are taken, and quantity of medication taken. This will also be reviewed both in the medical record and upon discussion with the participant at the postoperative visits. Assessment of the time spent in the recovery room, time spent in Phase 2 of recovery, and time to discharge from the hospital (total time between the end of surgery to discharge from hospital), will be obtained via review of the medical record. At the first postoperative visit, participants will undergo a routine interview that includes discussion of their pain control, analgesic and antiemetic use, recovery process, and overall satisfaction. The medical record will be reviewed for any unplanned postoperative hospital readmissions related to the surgery.
Group 2: To prospectively determine the effect of PVB on perioperative pain and postoperative recovery following breast augmentation. Patient-reported pain assessments (including a numeric rating scale) will be used to evaluate the primary endpoint (pain scores on postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this study, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the PACU, average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, the occurrence of unplanned hospital admission will be evaluated, PONV assessed, overall satisfaction, patients' assessment of quality of recovery as determined by a validated survey, and complications will be documented. This data will be obtained through review of medical records, surveys, and postoperative diaries.
The procedures will be the same as those described for Group 1, except patients will be undergoing planned breast augmentation.
Groups 3 and 4: To prospectively compare the standard of care for ambulatory breast surgery to "fast track" (also known as "enhanced recovery") strategies for breast surgery by assessing pain scores, pain medication and antiemetic use, development of nausea/vomiting, time to discharge, and patient satisfaction.
For the third serial Group in the study, patients electing to undergo breast reduction surgery will be invited to participate in the study at their preoperative visit. For the fourth Group in the study, all procedures will be the same as described in this section, but the patients will be undergoing breast augmentation surgery (not breast reduction). All patients choosing to take part in the study will be consented prior to their procedure. The study participants will be randomized, using block randomization, a computer-generated randomization template, and sealed, numbered, and opaque envelopes, to either receive (a) perioperative pain, nausea, and recovery strategies as part of our Enhanced Recovery after Breast Surgery (ERABS) protocol, or (b) perioperative instructions, anesthesia and medications as per our institution's current standard of care for elective breast reduction or breast augmentation.
Validated pain assessments will be used to evaluate the primary endpoint (pain scores on postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this study, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the PACU, average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, and the occurrence of unplanned hospital admission will be evaluated, occurrence of PONV assessed, assessment of recovery, overall satisfaction, and complications documented. This data will be obtained through review of medical records, questionnaires, and postoperative diaries.
- Conditions
- Pain, Acute, Nausea, Vomiting, Postoperative, Opioid Use, Satisfaction
- Being tested
- Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Enhanced recovery after breast surgery (ERABS) strategies, Sham paravertebral block using saline, Paravertebral block using local anesthetic
- Medical subject headings
- Acute Pain, Nausea, Postoperative Nausea and Vomiting, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile salineProcedure or surgery
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.
Enhanced recovery after breast surgery (ERABS) strategiesOther
For comparing ERABS strategies to current standard of care, the following perioperative strategies will be utilized:
- Standardized written information given preoperatively.
- Allow clear liquids for up to 2 hours prior to arrival at the surgery center.
- Use paravertebral block to augment postoperative pain control.
- Standardized multimodal analgesic regimen
- Antiemetics
- Easily accessible call-in or walk-in postop care/support
The proposed strategies differ from standard of care in the following ways:
- PVB is less commonly used in elective surgery.
- Patients do not eat or drink after midnight.
- There is no standardized preoperative information packet.
- Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers.
Sham paravertebral block using salineProcedure or surgery
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of sterile saline will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.
Paravertebral block using local anestheticDrug
Use of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Arm A | Experimental | Breast reduction with Paravertebral block using local anesthetic. Receives: Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Drug: Paravertebral block using local anesthetic |
| Group 1 Arm B | Sham comparator | Breast reduction with Sham paravertebral block using saline. Receives: Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Procedure: Sham paravertebral block using saline |
| Group 2 Arm A | Experimental | Breast augmentation with Paravertebral block using local anesthetic. Receives: Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Drug: Paravertebral block using local anesthetic |
| Group 2 Arm B | Sham comparator | Breast augmentation with Sham paravertebral block using saline. Receives: Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Procedure: Sham paravertebral block using saline |
| Group 3 Arm A | Experimental | Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies. Receives: Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Other: Enhanced recovery after breast surgery (ERABS) strategies |
| Group 3 Arm B | No intervention | Breast reduction, standard perioperative management. |
| Group 4 Arm A | Experimental | Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies. Receives: Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Other: Enhanced recovery after breast surgery (ERABS) strategies; Drug: Paravertebral block using local anesthetic |
| Group 4 Arm B | No intervention | Breast augmentation, standard perioperative management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scores, Rated by Patient on 0-10 Scale
Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1). Higher scores indicates higher levels of pain.
Measured: Postoperative day 1
Secondary outcomes (7)
Numerical Pain Scores, Rated by Patient on 0-10 Scale
Pain scores in Post Anesthesia Care Unit (PACU) / recovery area. Pain scored from 0-10 where higher scores indicates higher levels of pain.
Measured: Day of surgery
Time Spent in Each Phase of Care Prior to Discharge
Time spent in recovery after surgery in the PACU and Phase II (the area of recovery that patients transition to between PACU and discharge)
Measured: Day of surgery
Time to Discharge to Home
Time between conclusion of surgery and discharge from the surgery center
Measured: Day of surgery
Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7
Measured: 1 week after surgery
Post-operative Nausea and Vomiting (Subjective Report) Measured as the Mean Incidence Reported Post-Operatively Day 7
Occurrence of nausea and vomiting after surgery
Measured: 1 week after surgery
Anti-emetic Requirements Measured as Number of Participants Taking Anti-nausea Medication Post-Operatively Day 7
Use of anti-nausea mediation postoperatively
Measured: 1 week after surgery
Patients' Assessment of Perceived Quality of Recovery Using Modified Quality of Recovery Survey (MQOR-40)
Patients' assessment of quality of recovery using validated 'quality of recovery 40' survey. This survey is scored from 1-5 where higher scores indicate better quality of recovery.
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start19 Oct 2017
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: per Research Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- There are four serial aims of this study. The overarching goal is to prospectively assess the use of PVB as an adjunct for postoperative pain control both alone and in the setting of related ERABS strategies in elective breast surgery (both breast reduction and breast augmentation, two of the most common non-oncologic breast operations performed in an ambulatory setting). The methodologies used to assess postoperative pain, the set of collective ERABS strategies, the potential risks and benefits of study participation, and the inclusion/exclusion criteria will be the same in the groups studying breast reduction and those studying breast augmentation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venkat K Rao, MD, MBA, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187080
- Sponsor's protocol ID
- 2016-1388
- Other IDs
- A539730, SMPH\SURGERY\DENT&P SRG, Protocol Version 4/9/2021
- Status last verified
- Aug 2024
- First submitted
- 1 Jun 2017
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonde C, Khorasani H, Eriksen K, Wolthers M, Kehlet H, Elberg J. Introducing the fast track surgery principles can reduce length of stay after autologous breast reconstruction using free flaps: A case control study. J Plast Surg Hand Surg. 2015;49(6):367-71. doi: 10.3109/2000656X.2015.1062387. Epub 2015 Jul 10.
PubMed 26161838Davis GM, Ringler SL, Short K, Sherrick D, Bengtson BP. Reduction mammaplasty: long-term efficacy, morbidity, and patient satisfaction. Plast Reconstr Surg. 1995 Oct;96(5):1106-10.
PubMed 7568486Parikh RP, Sharma K, Guffey R, Myckatyn TM. Preoperative Paravertebral Block Improves Postoperative Pain Control and Reduces Hospital Length of Stay in Patients Undergoing Autologous Breast Reconstruction after Mastectomy for Breast Cancer. Ann Surg Oncol. 2016 Dec;23(13):4262-4269. doi: 10.1245/s10434-016-5471-1. Epub 2016 Aug 3.
PubMed 27489056Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.
PubMed 20947592Anderson AD, McNaught CE, MacFie J, Tring I, Barker P, Mitchell CJ. Randomized clinical trial of multimodal optimization and standard perioperative surgical care. Br J Surg. 2003 Dec;90(12):1497-504. doi: 10.1002/bjs.4371.
PubMed 14648727Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
PubMed 21236454Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PubMed 9175983Arsalani-Zadeh R, ElFadl D, Yassin N, MacFie J. Evidence-based review of enhancing postoperative recovery after breast surgery. Br J Surg. 2011 Feb;98(2):181-96. doi: 10.1002/bjs.7331.
PubMed 21104705Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.
PubMed 15562083Dabbagh A, Elyasi H. The role of paravertebral block in decreasing postoperative pain in elective breast surgeries. Med Sci Monit. 2007 Oct;13(10):CR464-7.
PubMed 17901854Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
PubMed 10825328Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
PubMed 23471753Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation
- ClinicalTrials.gov ID
- NCT03187080
- Acronym / sponsor ID
- 2016-1388
- Conditions
- Pain, Acute, Nausea, Vomiting, Postoperative, Opioid Use, Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: per Research Hold
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide.
The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. The investigators will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.
Detailed description
Bilateral breast reduction and bilateral breast augmentation are both routine plastic surgery procedures commonly performed on an outpatient basis. While patient satisfaction following these procedures is high, postoperative pain management can be challenging, resulting in decreased patient satisfaction, delayed recovery including delayed return to work and daily activities, increased opioid pain medication requirements and occasionally unplanned hospital admissions, surgical complications, and increased cost of care.
PVB is a common procedure used for analgesia in breast surgery in combination with multimodal perioperative pain regimens, though its use has not been formally studied in a prospective fashion. To date, no prospective, randomized, blinded study has been performed to evaluate the efficacy of PVB on perioperative pain management in this patient population.
The overarching goal of this study is to evaluate the safety and efficacy of PVB alone, as well as in conjunction with a global set of perioperative enhanced recovery strategies in elective breast surgery. The investigators hypothesize that the use of such strategies will improve the patient experience of breast reduction and augmentation beyond the current standard of care.
There are four serial aims of this study. The overarching goal of the study is to prospectively assess the use of PVB as an adjunct for postoperative pain control both alone and in the setting of related ERABS strategies in elective breast surgery (both breast reduction and breast augmentation, two of the most common non-oncologic breast operations performed in an ambulatory setting). The methodologies used to assess postoperative pain, the set of collective ERABS strategies, the potential risks and benefits of study participation, and the inclusion/exclusion criteria will be the same in the groups studying breast reduction and those studying breast augmentation.
Following completion of all 4 groups, the investigators will be able to assess the impact of PVB alone as well as the impact of ERABS strategies in both breast reduction and breast augmentation.
The primary aim in all four groups in this study is to evaluate postoperative pain scores in patients receiving either paravertebral block or ERABS strategies compared to patients who do not receive these interventions. Additional outcomes include use of analgesic and antiemetic medication, development of PONV, time to discharge, patients' assessment of quality of recovery as determined by a validated survey and overall patient satisfaction.
Group 1: To prospectively determine the effect of PVB on perioperative pain and postoperative recovery following breast reduction. Patient-reported pain assessments (including a numeric rating scale) will be used to evaluate the primary endpoint (pain scores on postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this study, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the Post Anesthesia Care Unit (PACU), average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, the occurrence of unplanned hospital admission will be evaluated, PONV assessed, overall satisfaction, patients' assessment of quality of recovery as determined by a validated survey, and complications documented. This data will be obtained through review of medical records, surveys, and postoperative diaries.
Patients electing to undergo breast reduction will be invited to participate in the study at their preoperative visit. All patients choosing to take part in the study will be consented prior to their procedure. The study participants will be randomized to one of two arms within each Group using block randomization. Details of the allocated group will be written on a piece of paper and placed inside sealed, opaque, and sequentially numbered, envelopes. Block randomization will be performed using a computer-generated number list and an Excel spreadsheet template. Block randomization will ensure equal numbers of subjects in each group. Either the anesthesiologist or the surgical team will open the envelope when the patient presents to UW Transformations Surgery Center or Madison Surgery Center (MSC) the day of surgery. The subject will be randomized to receive either (a) standard postoperative nausea and pain control as well as a sham superficial injection of normal saline or (b) PVB in addition to standard postoperative nausea and pain control. PVB and sham superficial injections of normal saline will be performed by a trained anesthesiology provider and will be performed in the routine manner. Surgery will take place in the usual fashion and participants will receive standard of care for pain and nausea control.
Following surgery, patients will be assessed for postoperative pain, nausea and vomiting. Assessment for postoperative pain will consist of a validated pain score survey administered prior to transfer to phase II postoperatively, on POD1, and at their one-week postoperative visit. Participants will also be asked to record, using a postoperative diary/log, when they take postoperative analgesics and antiemetics, which medications are taken, and quantity of medication taken. This will also be reviewed both in the medical record and upon discussion with the participant at the postoperative visits. Assessment of the time spent in the recovery room, time spent in Phase 2 of recovery, and time to discharge from the hospital (total time between the end of surgery to discharge from hospital), will be obtained via review of the medical record. At the first postoperative visit, participants will undergo a routine interview that includes discussion of their pain control, analgesic and antiemetic use, recovery process, and overall satisfaction. The medical record will be reviewed for any unplanned postoperative hospital readmissions related to the surgery.
Group 2: To prospectively determine the effect of PVB on perioperative pain and postoperative recovery following breast augmentation. Patient-reported pain assessments (including a numeric rating scale) will be used to evaluate the primary endpoint (pain scores on postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this study, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the PACU, average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, the occurrence of unplanned hospital admission will be evaluated, PONV assessed, overall satisfaction, patients' assessment of quality of recovery as determined by a validated survey, and complications will be documented. This data will be obtained through review of medical records, surveys, and postoperative diaries.
The procedures will be the same as those described for Group 1, except patients will be undergoing planned breast augmentation.
Groups 3 and 4: To prospectively compare the standard of care for ambulatory breast surgery to "fast track" (also known as "enhanced recovery") strategies for breast surgery by assessing pain scores, pain medication and antiemetic use, development of nausea/vomiting, time to discharge, and patient satisfaction.
For the third serial Group in the study, patients electing to undergo breast reduction surgery will be invited to participate in the study at their preoperative visit. For the fourth Group in the study, all procedures will be the same as described in this section, but the patients will be undergoing breast augmentation surgery (not breast reduction). All patients choosing to take part in the study will be consented prior to their procedure. The study participants will be randomized, using block randomization, a computer-generated randomization template, and sealed, numbered, and opaque envelopes, to either receive (a) perioperative pain, nausea, and recovery strategies as part of our Enhanced Recovery after Breast Surgery (ERABS) protocol, or (b) perioperative instructions, anesthesia and medications as per our institution's current standard of care for elective breast reduction or breast augmentation.
Validated pain assessments will be used to evaluate the primary endpoint (pain scores on postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this study, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the PACU, average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, and the occurrence of unplanned hospital admission will be evaluated, occurrence of PONV assessed, assessment of recovery, overall satisfaction, and complications documented. This data will be obtained through review of medical records, questionnaires, and postoperative diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- There are four serial aims of this study. The overarching goal is to prospectively assess the use of PVB as an adjunct for postoperative pain control both alone and in the setting of related ERABS strategies in elective breast surgery (both breast reduction and breast augmentation, two of the most common non-oncologic breast operations performed in an ambulatory setting). The methodologies used to assess postoperative pain, the set of collective ERABS strategies, the potential risks and benefits of study participation, and the inclusion/exclusion criteria will be the same in the groups studying breast reduction and those studying breast augmentation.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Arm A | Experimental | Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Drug: Paravertebral block using local anestheticBreast reduction with Paravertebral block using local anesthetic. |
| Group 1 Arm B | Sham comparator | Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Procedure: Sham paravertebral block using salineBreast reduction with Sham paravertebral block using saline. |
| Group 2 Arm A | Experimental | Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Drug: Paravertebral block using local anestheticBreast augmentation with Paravertebral block using local anesthetic. |
| Group 2 Arm B | Sham comparator | Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Procedure: Sham paravertebral block using salineBreast augmentation with Sham paravertebral block using saline. |
| Group 3 Arm A | Experimental | Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Other: Enhanced recovery after breast surgery (ERABS) strategiesBreast reduction with Enhanced recovery after breast surgery (ERABS) strategies. |
| Group 3 Arm B | No intervention | –Breast reduction, standard perioperative management. |
| Group 4 Arm A | Experimental | Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Other: Enhanced recovery after breast surgery (ERABS) strategies, Drug: Paravertebral block using local anestheticBreast augmentation with Enhanced recovery after breast surgery (ERABS) strategies. |
| Group 4 Arm B | No intervention | –Breast augmentation, standard perioperative management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal to and greater than 18 years.
- Medically cleared to undergo elective breast surgery (including associated anesthesia) at UW Transformations Surgery Center or Madison Surgery Center (MSC).
- Undergoing bilateral breast augmentation or bilateral breast reduction by the PI (Dr. Venkat Rao).
Key exclusion criteria (14 listed)
- Minors or under the age of 18
- Pregnant or breast feeding women
- Incarcerated women
- Males
- Individuals unable to give consent due to another condition such as impaired decision-making capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile salineParavertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space. | Procedure or surgery | Group 1 Arm A, Group 1 Arm B, Group 2 Arm A, Group 2 Arm B, Group 3 Arm A, Group 4 Arm A |
| Enhanced recovery after breast surgery (ERABS) strategiesFor comparing ERABS strategies to current standard of care, the following perioperative strategies will be utilized: * Standardized written information given preoperatively. * Allow clear liquids for up to 2 hours prior to arrival at the surgery center. * Use paravertebral block to augment postoperative pain control. * Standardized multimodal analgesic regimen * Antiemetics * Easily accessible call-in or walk-in postop care/support The proposed strategies differ from standard of care in the following ways: * PVB is less commonly used in elective surgery. * Patients do not eat or drink after midnight. * There is no standardized preoperative information packet. * Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers. | Other | Group 3 Arm A, Group 4 Arm A |
| Sham paravertebral block using salineParavertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of sterile saline will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space. | Procedure or surgery | Group 1 Arm B, Group 2 Arm B |
| Paravertebral block using local anestheticUse of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups. | Drug | Group 1 Arm A, Group 2 Arm A, Group 4 Arm A |
Primary outcome
Numerical Pain Scores, Rated by Patient on 0-10 Scale
Time frame: Postoperative day 1
Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1). Higher scores indicates higher levels of pain.
7 secondary outcomes
Numerical Pain Scores, Rated by Patient on 0-10 Scale
Time frame: Day of surgery
Time Spent in Each Phase of Care Prior to Discharge
Time frame: Day of surgery
Time to Discharge to Home
Time frame: Day of surgery
Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7
Time frame: 1 week after surgery
Post-operative Nausea and Vomiting (Subjective Report) Measured as the Mean Incidence Reported Post-Operatively Day 7
Time frame: 1 week after surgery
Anti-emetic Requirements Measured as Number of Participants Taking Anti-nausea Medication Post-Operatively Day 7
Time frame: 1 week after surgery
Patients' Assessment of Perceived Quality of Recovery Using Modified Quality of Recovery Survey (MQOR-40)
Time frame: 1 week after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26161838Bonde C, Khorasani H, Eriksen K, Wolthers M, Kehlet H, Elberg J. Introducing the fast track surgery principles can reduce length of stay after autologous breast reconstruction using free flaps: A case control study. J Plast Surg Hand Surg. 2015;49(6):367-71. doi: 10.3109/2000656X.2015.1062387. Epub 2015 Jul 10.
- Background: PubMed 7568486Davis GM, Ringler SL, Short K, Sherrick D, Bengtson BP. Reduction mammaplasty: long-term efficacy, morbidity, and patient satisfaction. Plast Reconstr Surg. 1995 Oct;96(5):1106-10.
- Background: PubMed 27489056Parikh RP, Sharma K, Guffey R, Myckatyn TM. Preoperative Paravertebral Block Improves Postoperative Pain Control and Reduces Hospital Length of Stay in Patients Undergoing Autologous Breast Reconstruction after Mastectomy for Breast Cancer. Ann Surg Oncol. 2016 Dec;23(13):4262-4269. doi: 10.1245/s10434-016-5471-1. Epub 2016 Aug 3.
- Background: PubMed 20947592Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.
- Background: PubMed 14648727Anderson AD, McNaught CE, MacFie J, Tring I, Barker P, Mitchell CJ. Randomized clinical trial of multimodal optimization and standard perioperative surgical care. Br J Surg. 2003 Dec;90(12):1497-504. doi: 10.1002/bjs.4371.
- Background: PubMed 21236454Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
- Background: PubMed 9175983Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
- Background: PubMed 21104705Arsalani-Zadeh R, ElFadl D, Yassin N, MacFie J. Evidence-based review of enhancing postoperative recovery after breast surgery. Br J Surg. 2011 Feb;98(2):181-96. doi: 10.1002/bjs.7331.
- Background: PubMed 15562083Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.
- Background: PubMed 17901854Dabbagh A, Elyasi H. The role of paravertebral block in decreasing postoperative pain in elective breast surgeries. Med Sci Monit. 2007 Oct;13(10):CR464-7.
- Background: PubMed 10825328Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
- Background: PubMed 23471753Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkat K Rao, MD, MBA principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Enhanced recovery after breast surgery (ERABS) strategies and Paravertebral block using local anesthetic in people with Pain, Acute and Nausea, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scores, Rated by Patient on 0-10 Scale (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187080, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.