Pain, PostoperativePhase 2NCT04919317
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
A Phase 2 study testing Dexamethasone 4mg and Saline in people with Pain, Postoperative and Mammaplasty, run by Temple University at 1 site in United States.
Trial summary
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain, Postoperative, Mammaplasty
- What is being tested?
- Dexamethasone 4mg and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 25 Nov 2020
- Phase
- Phase 2
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18-80
- Bilateral reduction mammaplasty
- American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
- Must choose to receive preoperative nerve block as part of pain management strategy
Who cannot join
- Allergy to dexamethasone or bupivacaine
- History of postoperative nausea and vomiting following anesthesia
- History of chronic pain conditions
- History of narcotic abuse or dependency
- History of chronic renal disease
- History of chronic liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.
Read the detailed description
The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.
Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.
The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.
- Conditions
- Pain, Postoperative, Mammaplasty
- Being tested
- Dexamethasone 4mg, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mgDrug
The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
SalineDrug
The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. Receives: Drug: Saline |
| Experimental | Experimental | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. Receives: Drug: Dexamethasone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
4-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
8-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
12-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
16-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
20-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
24-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Measured: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Narcotic Consumption
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
Measured: Up to 24 hours postoperatively
Secondary outcomes (17)
Initial Blood Pressure
Systolic blood pressure
Measured: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
4-hour Blood Pressure
Systolic blood pressure
Measured: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
8-hour Blood Pressure
Systolic blood pressure
Measured: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
12-hour Blood Pressure
Systolic blood pressure
Measured: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
16-hour Blood Pressure
Systolic blood pressure
Measured: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
20-hour Blood Pressure
Systolic blood pressure
Measured: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
24-hour Blood Pressure
Systolic blood pressure
Measured: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Initial Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
4-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
8-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
12-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
16-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
20-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
24-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Measured: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Number of Patients Administered Anti-emetics at 4-hour Intervals
Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals
Measured: Initial, 4, 8, 12, 16, 20, and 24 hours
Short-form 36-item (Sf-36) Quality of Life Questionnaire
Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.
Measured: 1 week to 2 months postoperatively
Rate of Wound Complications
Assessment of wound complications during any postoperative clinic visit
Measured: 1 week to 2 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start29 Sep 2017
- Primary completion7 Nov 2020
- Study completion25 Nov 2020
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 (8)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew A Gassman, MD, FACS, Principal investigator, Lewis Katz School of Medicine at Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919317
- Sponsor's protocol ID
- 24361
- Status last verified
- Oct 2023
- First submitted
- 21 May 2021
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available to other researchers if necessary
Publications
Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
PubMed 8880841Broyles JM, Tuffaha SH, Williams EH, Glickman L, George TA, Lee Dellon A. Pain after breast surgery: Etiology, diagnosis, and definitive management. Microsurgery. 2016 Oct;36(7):535-538. doi: 10.1002/micr.30055. Epub 2016 Apr 4.
PubMed 27043853Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
PubMed 31741068Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099Vetriselvan P, Mandal B, Bhatia N, Jain V. Effect of dexamethasone on analgesic efficacy of transverse abdominis plane block in laparoscopic gynecological procedures: A prospective randomized clinical study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):165-169. doi: 10.4103/joacp.JOACP_374_17.
PubMed 31303703Maher DP, Serna-Gallegos D, Mardirosian R, Thomas OJ, Zhang X, McKenna R, Yumul R, Zhang V. The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone. Pain Med. 2017 Jun 1;18(6):1152-1160. doi: 10.1093/pm/pnw149.
PubMed 27473629Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
PubMed 28033159Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.
PubMed 30066465
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04919317
- Acronym / sponsor ID
- 24361
- Conditions
- Pain, Postoperative, Mammaplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.
Detailed description
The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.
Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.
The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: SalineControl group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Experimental | Experimental | Drug: Dexamethasone 4mgExperimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Age 18-80
- Bilateral reduction mammaplasty
- American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
- Must choose to receive preoperative nerve block as part of pain management strategy
Key exclusion criteria (6 listed)
- Allergy to dexamethasone or bupivacaine
- History of postoperative nausea and vomiting following anesthesia
- History of chronic pain conditions
- History of narcotic abuse or dependency
- History of chronic renal disease
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 |
|---|---|---|
| Dexamethasone 4mgThe experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty. | Drug | Experimental |
| SalineThe control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty. | Drug | Control |
Primary outcome
Initial Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
4-hour Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
8-hour Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
12-hour Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
16-hour Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
20-hour Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
24-hour Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Narcotic Consumption
Time frame: Up to 24 hours postoperatively
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
17 secondary outcomes
Initial Blood Pressure
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
4-hour Blood Pressure
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
8-hour Blood Pressure
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
12-hour Blood Pressure
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
16-hour Blood Pressure
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
20-hour Blood Pressure
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
24-hour Blood Pressure
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Initial Oxygen Saturation
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
4-hour Oxygen Saturation
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
8-hour Oxygen Saturation
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
12-hour Oxygen Saturation
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
16-hour Oxygen Saturation
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
20-hour Oxygen Saturation
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
24-hour Oxygen Saturation
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Number of Patients Administered Anti-emetics at 4-hour Intervals
Time frame: Initial, 4, 8, 12, 16, 20, and 24 hours
Short-form 36-item (Sf-36) Quality of Life Questionnaire
Time frame: 1 week to 2 months postoperatively
Rate of Wound Complications
Time frame: 1 week to 2 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8880841Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
- Background: PubMed 27043853Broyles JM, Tuffaha SH, Williams EH, Glickman L, George TA, Lee Dellon A. Pain after breast surgery: Etiology, diagnosis, and definitive management. Microsurgery. 2016 Oct;36(7):535-538. doi: 10.1002/micr.30055. Epub 2016 Apr 4.
- Background: PubMed 31741068Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
- Background: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Background: PubMed 31303703Vetriselvan P, Mandal B, Bhatia N, Jain V. Effect of dexamethasone on analgesic efficacy of transverse abdominis plane block in laparoscopic gynecological procedures: A prospective randomized clinical study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):165-169. doi: 10.4103/joacp.JOACP_374_17.
- Background: PubMed 27473629Maher DP, Serna-Gallegos D, Mardirosian R, Thomas OJ, Zhang X, McKenna R, Yumul R, Zhang V. The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone. Pain Med. 2017 Jun 1;18(6):1152-1160. doi: 10.1093/pm/pnw149.
- Background: PubMed 28033159Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
- Background: PubMed 30066465Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to other researchers if necessary
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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.
Andrew A Gassman, MD, FACS principal investigator
Lewis Katz School of Medicine at Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone 4mg and Saline in people with Pain, Postoperative and Mammaplasty, run by Temple University 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 11 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Jul 2022). 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?
Initial Visual Analog Scale (VAS) Pain Scores (time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)). The study lists 8 primary outcomes in all. 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 NCT04919317, which also lists 8 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 11 Oct 2023.