MacromastiaPhase 4NCT05898087
Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
A Phase 4 study testing Marcaine 0.25 % Injectable Solution and Saline in people with Macromastia and Post-operative Pain, run by Connecticut Children's Medical Center at 2 sites in United States.
Trial summary
The main question this randomized control trial aims to answer is: Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty Participants will be randomized into the study group that intraoperatively receives… Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Macromastia, Post-operative Pain
- What is being tested?
- Marcaine 0.25 % Injectable Solution and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2022to 8 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Age 13-25 at the time of surgery
- Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025.
- Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist.
- Patients already taking narcotics at the time of surgery.
- Patients with a history of hepatic or renal dysfunction.
- Patients with known allergy to bupivacaine.
- Patients who are pregnant, determined by urine testing in pre-operative area.
- Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores.
Show all 9Show fewer
- Patients with significant post-operative complications
- Patients not meeting inclusion criteria.
- Patients lost to follow-up- they must be seen within 1 week and 4 weeks post-operatively
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Connecticut Children's
Farmington, Connecticut, 06032
Connecticut Children's
Hartford, Connecticut, 06106
About this study
The main question this randomized control trial aims to answer is:
- Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty
Read more
Participants will be randomized into the study group that intraoperatively receives 30cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 30cc of injectable saline subpectorally. All participants will keep a pain log and pain medication log at home for the first week following surgery.
Researchers will compare to see if patients who receive subpectoral bupivacaine have lower pain scores in the PACU, and lower use of narcotics post-operatively when compared to the control group who receive injectable saline.
Read the detailed description
- All team members will be extensively trained on the proceedings of this trial
- Patients will be recruited at their initial consultation, or subsequent pre-operative visit.
- All patients that are approached will be recorded into an excel sheet. If they decline the study- this will be listed along with any provided reasoning for declining.
- Once consent is obtained, the patient will be randomized into either the study group (receiving intraoperative subpectoral bupivacaine) or the control group (will not receive subpectoral bupivacaine.) Block randomization will be performed using randomizer.org. For every forty patients, twenty will be randomized into the control group, and twenty into the bupivacaine group. Patients will be blinded to the which group they are placed in. The PI and study staff are not blinded.
- Per standard protocol, patients will undergo urine pregnancy testing in the pre-operative area. If results are positive, patients will be informed of the results in a private area. Surgery will be postponed and patients will be then excluded from the study.
- Patients will undergo their procedure with their assigned intervention. Intra-operative anesthetic and pain control regimens will otherwise be standardized with the anesthesia team to remove other confounding factors/variables.
- Administration of the saline/bupivacaine will be just below the fascia of the pectroalis major. This will occur following resection of the specimen and achievement of hemostasis, prior to closure of the wounds. Injections will be in a fan-like pattern, beginning at the inferolateral border of the pectoral is muscle, extending superomedially with injection, spanning the anterior surface of the pectroalis major. This will be performed under direct visualization; no imaging assistance is necessary. Each patient will receive 5 injections, 3mL per injection bilaterally. A total of 30mL of saline or bupivacaine will be injected.
- PACU nurses will record pain scores upon arrival into the PACU, as well as upon discharge home from the hospital. All patients will receive the same amount of prescribed narcotic. They will be sent home with a log. Patients will record a daily pain score, and the number of doses of ibuprofen, acetaminophen and oxycodone.
- As an internal quality control measure, research staff will call patients within 72 hours from surgery to ensure they are completing the pain score and medication log daily.
- The clinician (MD, PA, or nurse) will go through the survey questions with patients at their 1 and 4 week post-operative visits. These questions are typical questions asked at follow-up and will not add significant time to the clinic visit. All clinical staff asking these surveys is familiar with the information. (see appendices)
- Data will be collected at the 1 and 4 week post-operative visit in the plastic surgery clinic Further data (PACU length of stay, PACU pain scores) will be determined by performing chart review.
- To minimize error and maximize quality, only a few clinicians (3-4 max) will be those obtaining the survey results in clinic. All questions will be asked by reading verbatim from the survey to avoid bias when questioning. Scores will be entered into an excel file each day at the end of clinic.
- The spreadsheet will be password protected to ensure patient privacy. Only the surgeon, PA and RN will have access to this.
- Interim analyses will be performed after 60 patients have undergone treatment in order to assess if the study is meeting the intended objectives.
- Conditions
- Macromastia, Post-operative Pain
- Being tested
- Marcaine 0.25 % Injectable Solution, Saline
- Keywords
- macromastia, post-operative pain, bupivacaine
- Medical subject headings
- Gigantomastia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine 0.25 % Injectable SolutionDrug
Also called bupivacaine 0.25% injectable solution
Patients in this arm will receive an injection of 20cc of injectable 0.25% bupivacaine solution. It will be injected in a fan-like pattern beneath the pectoralis fascia
SalineDrug
Also called injectable saline
Patients in this arm will receive an injection of 20cc of injectable saline. It will be injected in a fan-like pattern beneath the pectoralis fascia
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 - Intervention | Experimental | Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia Receives: Drug: Marcaine 0.25 % Injectable Solution |
| Study Group 2 - Control | Placebo comparator | Participants in this group will receive 20cc of subpectoral saline injected into the fascia Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Pain Score
Post-operative pain score will be patient reported on a rating scale of 1-10. This will be recorded by the PACU nurse upon admission and upon discharge from the PACU. Patients will subsequently record a daily pain score in a home log daily until their 1 week follow-up visit. Scores will be recorded using the home log provided by the patient. We will also utilize chart review to record PACU pain score from the immediate post-operative time period.
Measured: Measured on day of surgery
Secondary outcomes (4)
Demographics
Demographics including age, race, ethnicity will be collected and recorded for all patients approached to enter the study.
Measured: Recorded when patient is enrolled
Total Amount of Narcotic Use
Narcotic use will be determined by chart review of the PACU record. The amount of narcotic pain medication will be recorded for each patient. Prescription narcotic use upon discharge will be patient-reported in their patient log.
Measured: Measured up until 4 weeks post-op
Days to Return to full activity
Return to full activity- will be categorized as returning to school, returning to light activity, or returning to full activity/heavy exercise.
Measured: Measured for 4 weeks post-op
Length of stay in post-anesthesia care unit (hours)
Length of stay in post-anesthesia care unit will be determined by chart review from time entering the PACU to time of discharge from the hospital.
Measured: Measured on day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Apr 2022
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MacromastiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Hughes, MD, MPH, Principal investigator, Connecticut Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898087
- Sponsor's protocol ID
- 21-167-CCMC
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team is comprised of the medical providers caring for these patients. The study information will be collected and stored on the secure hospital server, password protected.
Publications
Wallace CC, Wetzel ME, Howell C, Vasconez HC. The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. Ann Plast Surg. 2021 Jun 1;86(6S Suppl 5):S632-S634. doi: 10.1097/SAP.0000000000002763.
PubMed 33625027Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.
PubMed 15923838Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.
PubMed 18650606
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
- ClinicalTrials.gov ID
- NCT05898087
- Acronym / sponsor ID
- 21-167-CCMC
- Conditions
- Macromastia, Post-operative Pain
- Keywords
- macromastia, post-operative pain, bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main question this randomized control trial aims to answer is:
- Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty
Participants will be randomized into the study group that intraoperatively receives 30cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 30cc of injectable saline subpectorally. All participants will keep a pain log and pain medication log at home for the first week following surgery.
Researchers will compare to see if patients who receive subpectoral bupivacaine have lower pain scores in the PACU, and lower use of narcotics post-operatively when compared to the control group who receive injectable saline.
Detailed description
- All team members will be extensively trained on the proceedings of this trial
- Patients will be recruited at their initial consultation, or subsequent pre-operative visit.
- All patients that are approached will be recorded into an excel sheet. If they decline the study- this will be listed along with any provided reasoning for declining.
- Once consent is obtained, the patient will be randomized into either the study group (receiving intraoperative subpectoral bupivacaine) or the control group (will not receive subpectoral bupivacaine.) Block randomization will be performed using randomizer.org. For every forty patients, twenty will be randomized into the control group, and twenty into the bupivacaine group. Patients will be blinded to the which group they are placed in. The PI and study staff are not blinded.
- Per standard protocol, patients will undergo urine pregnancy testing in the pre-operative area. If results are positive, patients will be informed of the results in a private area. Surgery will be postponed and patients will be then excluded from the study.
- Patients will undergo their procedure with their assigned intervention. Intra-operative anesthetic and pain control regimens will otherwise be standardized with the anesthesia team to remove other confounding factors/variables.
- Administration of the saline/bupivacaine will be just below the fascia of the pectroalis major. This will occur following resection of the specimen and achievement of hemostasis, prior to closure of the wounds. Injections will be in a fan-like pattern, beginning at the inferolateral border of the pectoral is muscle, extending superomedially with injection, spanning the anterior surface of the pectroalis major. This will be performed under direct visualization; no imaging assistance is necessary. Each patient will receive 5 injections, 3mL per injection bilaterally. A total of 30mL of saline or bupivacaine will be injected.
- PACU nurses will record pain scores upon arrival into the PACU, as well as upon discharge home from the hospital. All patients will receive the same amount of prescribed narcotic. They will be sent home with a log. Patients will record a daily pain score, and the number of doses of ibuprofen, acetaminophen and oxycodone.
- As an internal quality control measure, research staff will call patients within 72 hours from surgery to ensure they are completing the pain score and medication log daily.
- The clinician (MD, PA, or nurse) will go through the survey questions with patients at their 1 and 4 week post-operative visits. These questions are typical questions asked at follow-up and will not add significant time to the clinic visit. All clinical staff asking these surveys is familiar with the information. (see appendices)
- Data will be collected at the 1 and 4 week post-operative visit in the plastic surgery clinic Further data (PACU length of stay, PACU pain scores) will be determined by performing chart review.
- To minimize error and maximize quality, only a few clinicians (3-4 max) will be those obtaining the survey results in clinic. All questions will be asked by reading verbatim from the survey to avoid bias when questioning. Scores will be entered into an excel file each day at the end of clinic.
- The spreadsheet will be password protected to ensure patient privacy. Only the surgeon, PA and RN will have access to this.
- Interim analyses will be performed after 60 patients have undergone treatment in order to assess if the study is meeting the intended objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 - Intervention | Experimental | Drug: Marcaine 0.25 % Injectable SolutionParticipants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia |
| Study Group 2 - Control | Placebo comparator | Drug: SalineParticipants in this group will receive 20cc of subpectoral saline injected into the fascia |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female
- Age 13-25 at the time of surgery
- Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025.
- Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist.
- Patients already taking narcotics at the time of surgery.
- Patients with a history of hepatic or renal dysfunction.
- Patients with known allergy to bupivacaine.
- Patients who are pregnant, determined by urine testing in pre-operative area.
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 |
|---|---|---|
| Marcaine 0.25 % Injectable SolutionAlso: bupivacaine 0.25% injectable solutionPatients in this arm will receive an injection of 20cc of injectable 0.25% bupivacaine solution. It will be injected in a fan-like pattern beneath the pectoralis fascia | Drug | Study Group 1 - Intervention |
| SalineAlso: injectable salinePatients in this arm will receive an injection of 20cc of injectable saline. It will be injected in a fan-like pattern beneath the pectoralis fascia | Drug | Study Group 2 - Control |
Primary outcome
Patient Reported Pain Score
Time frame: Measured on day of surgery
Post-operative pain score will be patient reported on a rating scale of 1-10. This will be recorded by the PACU nurse upon admission and upon discharge from the PACU. Patients will subsequently record a daily pain score in a home log daily until their 1 week follow-up visit. Scores will be recorded using the home log provided by the patient. We will also utilize chart review to record PACU pain score from the immediate post-operative time period.
4 secondary outcomes
Demographics
Time frame: Recorded when patient is enrolled
Total Amount of Narcotic Use
Time frame: Measured up until 4 weeks post-op
Days to Return to full activity
Time frame: Measured for 4 weeks post-op
Length of stay in post-anesthesia care unit (hours)
Time frame: Measured on day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Results publication: PubMed 33625027Wallace CC, Wetzel ME, Howell C, Vasconez HC. The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. Ann Plast Surg. 2021 Jun 1;86(6S Suppl 5):S632-S634. doi: 10.1097/SAP.0000000000002763.
- Results publication: PubMed 15923838Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.
- Results publication: PubMed 18650606Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.
- Individual participant dataSharing planned: Yes. The research team is comprised of the medical providers caring for these patients. The study information will be collected and stored on the secure hospital server, password protected.
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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.
Christopher Hughes, MD, MPH principal investigator
Connecticut Children's
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Marcaine 0.25 % Injectable Solution and Saline in people with Macromastia and Post-operative Pain, run by Connecticut Children's Medical Center at 2 sites 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 9 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Reported Pain Score (time frame: Measured on day of surgery). 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 NCT05898087, which also lists 3 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 31 Jul 2026.