Pain, BreastPhase 4NCT03722927
The Use Of Liposomal Bupivacaine For Pain Control
A Phase 4 study testing Bupivacaine and Liposomal Bupivacaine in people with Pain, Breast, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Breast
- What is being tested?
- Bupivacaine and Liposomal Bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 29 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
- Age ≥ 18 years
- Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
- Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.
Who cannot join
- Patients who receive an autologous tissue reconstruction.
- Patients who receive a unilateral reconstruction.
- Patients who are expected to undergo axillary lymph node dissection
- Patients who have undergone breast irradiation
- Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
- Patients who are wards of the state
Show all 11Show fewer
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
- Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
- Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
- Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
- Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
Read the detailed description
Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.
- Conditions
- Pain, Breast
- Being tested
- Bupivacaine, Liposomal Bupivacaine
- Keywords
- Bupivacaine, Liposomal Bupivacaine, Mastectomy, Breast Reconstruction, Pain Control
- Medical subject headings
- Mastodynia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Liposomal BupivacaineDrug
Also called Exparel
While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Group | Experimental | Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction Receives: Drug: Bupivacaine |
| Liposomal Bupivacaine Group | Experimental | Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction Receives: Drug: Liposomal Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Visual Analog Scores
This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes.
Measured: 48 hours
Secondary outcomes (6)
Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)
This will be measured during first 48 hours postoperatively
Measured: 48 hours
Number of Morphine Doses Across All Subjects
This will be measured by the number of doses within the first month postoperatively and recorded on pain medication daily diary kept by subject.
Measured: 1 Month
Length of Stay for Hospitalization
The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.
Measured: up to 47 Hours
Readmission Rates to the Hospital
Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded
Measured: Month 2
Frequency of Postoperative Opioid Related Adverse Effects
Frequency of postoperative opioid related adverse effects within the first week of surgery will be recorded. This includes nausea, vomiting, pruritus, allergy, respiratory depression.
Measured: Postoperatively, 1 week
Pain Intensity With Movement
This will be measured by using the Pain Assessment Questionnaire. Total scores are 0-50 with higher scores denoting worse outcomes.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start14 Jun 2018
- Primary completion29 Jan 2020
- Study completion29 Jan 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 (29)Papers the sponsor has linked to this study.
- Other trials for Pain, BreastStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women of all races and ethnicity who meet the above-described eligibility criteria are eligible to participate in this study. Approximately 5% of study participants to be Hispanic/Latino (N=5), 10% Black or African American (N=10), 1% American Indian/Alaska Native (N=1), and 5% Asian (N=5).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher M Runyan, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722927
- Sponsor's protocol ID
- IRB00045562
- Status last verified
- May 2021
- First submitted
- 22 Oct 2018
- Last updated
- 27 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lovecchio F, Jordan SW, Lim S, Fine NA, Kim JY. Risk Factors for Complications Differ Between Stages of Tissue-Expander Breast Reconstruction. Ann Plast Surg. 2015 Sep;75(3):275-80. doi: 10.1097/SAP.0000000000000109.
PubMed 24691330Butz DR, Shenaq DS, Rundell VL, Kepler B, Liederbach E, Thiel J, Pesce C, Murphy GS, Sisco M, Howard MA. Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2015 Jun 5;3(5):e391. doi: 10.1097/GOX.0000000000000355. eCollection 2015 May.
PubMed 26090281Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.
PubMed 25003439Shekhawat L, Busheri L, Dixit S, Patel C, Dhar U, Koppiker C. Patient-Reported Outcomes Following Breast Reconstruction Surgery and Therapeutic Mammoplasty: Prospective Evaluation 1 Year Post-Surgery with BREAST-Q Questionnaire. Indian J Surg Oncol. 2015 Dec;6(4):356-62. doi: 10.1007/s13193-015-0432-x. Epub 2015 Jul 23.
PubMed 27065661Wallace 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 8880841Morrison JE Jr, Jacobs VR. Reduction or elimination of postoperative pain medication after mastectomy through use of a temporarily placed local anesthetic pump vs. control group. Zentralbl Gynakol. 2003 Jan;125(1):17-22. doi: 10.1055/s-2003-40364.
PubMed 12877104Lee MJ, Daniels SL, Wild JRL, Wilson TR; SYSuRG RAGeS Group. Readmissions after general surgery: a prospective multicenter audit. J Surg Res. 2017 Mar;209:53-59. doi: 10.1016/j.jss.2016.09.020. Epub 2016 Sep 19.
PubMed 28032571Bonnet F, Marret E. Influence of anaesthetic and analgesic techniques on outcome after surgery. Br J Anaesth. 2005 Jul;95(1):52-8. doi: 10.1093/bja/aei038. Epub 2004 Dec 3.
PubMed 15579487Strang P. Cancer pain--a provoker of emotional, social and existential distress. Acta Oncol. 1998;37(7-8):641-4. doi: 10.1080/028418698429973.
PubMed 10050980Zielinski T, Lorenc-Podgorska K, Antoszewski B. Why women who have mastectomy decide not to have breast reconstruction? Pol Przegl Chir. 2015 Feb 3;86(10):451-5. doi: 10.2478/pjs-2014-0081.
PubMed 25720103American Society of Plastic Surgeons. (2015). Plastic surgery statistics report. Retrived from https://d2wirczt3b6wjm.cloudfront.net/News/Statistics/2015/plastic-surgery-statistics-full-report-2015.pdf
Gassman AA, Yoon AP, Festekjian J, Da Lio AL, Tseng CY, Crisera C. Comparison of immediate postoperative pain in implant-based breast reconstructions. J Plast Reconstr Aesthet Surg. 2016 May;69(5):604-16. doi: 10.1016/j.bjps.2015.12.009. Epub 2016 Jan 7.
PubMed 26947947Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
PubMed 26204387Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. 2014 Feb;30(2):102-10. doi: 10.1097/AJP.0b013e318288e1f6.
PubMed 23446090Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24.
PubMed 26507422
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03722927
- Acronym / sponsor ID
- IRB00045562
- Conditions
- Pain, Breast
- Keywords
- Bupivacaine, Liposomal Bupivacaine, Mastectomy, Breast Reconstruction, Pain Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 27 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
Detailed description
Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Women of all races and ethnicity who meet the above-described eligibility criteria are eligible to participate in this study. Approximately 5% of study participants to be Hispanic/Latino (N=5), 10% Black or African American (N=10), 1% American Indian/Alaska Native (N=1), and 5% Asian (N=5).
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Group | Experimental | Drug: BupivacaineParticipants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction |
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal BupivacaineParticipants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
- Age ≥ 18 years
- Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
- Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.
Key exclusion criteria (11 listed)
- Patients who receive an autologous tissue reconstruction.
- Patients who receive a unilateral reconstruction.
- Patients who are expected to undergo axillary lymph node dissection
- Patients who have undergone breast irradiation
- Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
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 |
|---|---|---|
| BupivacaineAlso: MarcaineWhile in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery. | Drug | Bupivacaine Group |
| Liposomal BupivacaineAlso: ExparelWhile in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery. | Drug | Liposomal Bupivacaine Group |
Primary outcome
Mean Visual Analog Scores
Time frame: 48 hours
This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes.
6 secondary outcomes
Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)
Time frame: 48 hours
Number of Morphine Doses Across All Subjects
Time frame: 1 Month
Length of Stay for Hospitalization
Time frame: up to 47 Hours
Readmission Rates to the Hospital
Time frame: Month 2
Frequency of Postoperative Opioid Related Adverse Effects
Time frame: Postoperatively, 1 week
Pain Intensity With Movement
Time frame: Up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24691330Lovecchio F, Jordan SW, Lim S, Fine NA, Kim JY. Risk Factors for Complications Differ Between Stages of Tissue-Expander Breast Reconstruction. Ann Plast Surg. 2015 Sep;75(3):275-80. doi: 10.1097/SAP.0000000000000109.
- Background: PubMed 26090281Butz DR, Shenaq DS, Rundell VL, Kepler B, Liederbach E, Thiel J, Pesce C, Murphy GS, Sisco M, Howard MA. Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2015 Jun 5;3(5):e391. doi: 10.1097/GOX.0000000000000355. eCollection 2015 May.
- Background: PubMed 25003439Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.
- Background: PubMed 27065661Shekhawat L, Busheri L, Dixit S, Patel C, Dhar U, Koppiker C. Patient-Reported Outcomes Following Breast Reconstruction Surgery and Therapeutic Mammoplasty: Prospective Evaluation 1 Year Post-Surgery with BREAST-Q Questionnaire. Indian J Surg Oncol. 2015 Dec;6(4):356-62. doi: 10.1007/s13193-015-0432-x. Epub 2015 Jul 23.
- 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 12877104Morrison JE Jr, Jacobs VR. Reduction or elimination of postoperative pain medication after mastectomy through use of a temporarily placed local anesthetic pump vs. control group. Zentralbl Gynakol. 2003 Jan;125(1):17-22. doi: 10.1055/s-2003-40364.
- Background: PubMed 28032571Lee MJ, Daniels SL, Wild JRL, Wilson TR; SYSuRG RAGeS Group. Readmissions after general surgery: a prospective multicenter audit. J Surg Res. 2017 Mar;209:53-59. doi: 10.1016/j.jss.2016.09.020. Epub 2016 Sep 19.
- Background: PubMed 15579487Bonnet F, Marret E. Influence of anaesthetic and analgesic techniques on outcome after surgery. Br J Anaesth. 2005 Jul;95(1):52-8. doi: 10.1093/bja/aei038. Epub 2004 Dec 3.
- Background: PubMed 10050980Strang P. Cancer pain--a provoker of emotional, social and existential distress. Acta Oncol. 1998;37(7-8):641-4. doi: 10.1080/028418698429973.
- Background: PubMed 25720103Zielinski T, Lorenc-Podgorska K, Antoszewski B. Why women who have mastectomy decide not to have breast reconstruction? Pol Przegl Chir. 2015 Feb 3;86(10):451-5. doi: 10.2478/pjs-2014-0081.
- BackgroundAmerican Society of Plastic Surgeons. (2015). Plastic surgery statistics report. Retrived from https://d2wirczt3b6wjm.cloudfront.net/News/Statistics/2015/plastic-surgery-statistics-full-report-2015.pdf
- Background: PubMed 26947947Gassman AA, Yoon AP, Festekjian J, Da Lio AL, Tseng CY, Crisera C. Comparison of immediate postoperative pain in implant-based breast reconstructions. J Plast Reconstr Aesthet Surg. 2016 May;69(5):604-16. doi: 10.1016/j.bjps.2015.12.009. Epub 2016 Jan 7.
Related trials for Pain, Breast
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
Christopher M Runyan, MD principal investigator
Wake Forest University Health Sciences
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 Bupivacaine and Liposomal Bupivacaine in people with Pain, Breast, run by Wake Forest University Health Sciences 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 4 inclusion and 11 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 27 Oct 2022. 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. 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 27 Oct 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?
Mean Visual Analog Scores (time frame: 48 hours). 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 NCT03722927, which also lists 29 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 27 Oct 2022.