Bupivacaine Injection for Postoperative Pain in Breast Reduction

Recruiting at 1 trial location

Overseen By Christopher Hughes, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Connecticut Children's Medical Center

Must not be taking: Narcotics

Disqualifiers: Substance use disorder, Chronic pain, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Day of surgery

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bupivacaine, an injectable anesthetic, can reduce pain after breast reduction surgery. It compares the effects of bupivacaine, injected during surgery, to a saline solution in managing pain and reducing the need for painkillers. The trial targets young women aged 13-25 who plan to undergo breast reduction surgery. Participants will maintain a pain and medication log for the first week post-surgery. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking narcotics at the time of surgery.

What is the safety track record for Marcaine 0.25 % Injectable Solution?

Research has shown that bupivacaine is safely used in many surgeries, including breast surgeries, and patients generally tolerate it well. Studies indicate that normal doses of bupivacaine rarely cause side effects, suggesting it is safe for managing post-surgical pain. This trial tests bupivacaine for pain relief after breast reduction surgery, and its safety in similar surgeries supports its use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of bupivacaine for postoperative pain in breast reduction surgery because it offers a targeted approach to pain management. Unlike traditional oral pain medications, bupivacaine is a local anesthetic injected directly into the fascia, where it can effectively numb the area and potentially reduce the need for systemic painkillers like opioids. This localized delivery means patients might experience fewer side effects compared to oral medications, making recovery more comfortable and safer.

What is the effectiveness track record for bupivacaine in reducing postoperative pain in breast reduction surgery?

Research shows that bupivacaine can reduce pain after surgery. In this trial, participants in Study Group 1 will receive bupivacaine, which previous studies have shown provides better pain relief than a saltwater injection, reducing the need for opioid painkillers. This indicates that bupivacaine can effectively manage pain after surgeries, such as breast reduction. Other studies also find that bupivacaine lowers pain levels in the first 48 hours post-surgery, making it a good option for reducing post-surgery pain. Participants in Study Group 2 will receive a saline injection as a control. ^{2 6 7 8 9}

Who Is on the Research Team?

Christopher Hughes, MD, MPH

Principal Investigator

Connecticut Children's

Are You a Good Fit for This Trial?

This trial is for female adolescents aged 13-21 undergoing breast reduction surgery at Connecticut Children's. They must be able to have a parent or guardian consent to the study. Excluded are those with substance use disorders, chronic pain managed by specialists, pre-surgery narcotic use, liver/kidney dysfunction, bupivacaine allergy, pregnancy, inability to report pain reliably, significant post-op complications or lost follow-up.

Inclusion Criteria

Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document

I am having a breast reduction surgery at Connecticut Children's between 2022 and 2025.

I am female.

Exclusion Criteria

You have difficulty speaking or understanding and may not be able to accurately tell us if you are in pain.

I have a history of substance use disorder or chronic pain managed by a specialist.

I must see my doctor within 1 and 4 weeks after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo bilateral reduction mammaplasty with either subpectoral bupivacaine or saline injections

Day of surgery

1 visit (in-person)

Post-operative Monitoring

Participants record daily pain scores and medication use in a home log for the first week following surgery

1 week

Home-based monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain score and narcotic use assessment

4 weeks

2 visits (in-person) at 1 and 4 weeks post-op

What Are the Treatments Tested in This Trial?

Interventions

• Marcaine 0.25 % Injectable Solution
• Saline

Trial Overview The study tests if injecting bupivacaine (a numbing medication) under the chest muscle during surgery reduces post-operative pain and narcotic use compared to saline (saltwater solution). Participants will be randomly assigned to receive either bupivacaine or saline and will track their pain and medication usage for one week after surgery.

How Is the Trial Designed?

Group I: Study Group 1 - Intervention Experimental Treatment 1 Intervention

Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia

Group II: Study Group 2 - Control Placebo Group 1 Intervention

Participants in this group will receive 20cc of subpectoral saline injected into the fascia

Saline is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Normal Saline for:

• General wound care
• Eye irrigation
• Skin cleansing

Approved in European Union as Sodium Chloride Solution for:

• Wound cleaning
• Eye washing
• Skin disinfection

Approved in Canada as Physiological Saline for:

• Wound irrigation
• Eye flushing
• General medical use

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

Published Research Related to This Trial

In a study of 100 women undergoing laparoscopic tubal sterilization, bupivacaine infiltration into the mesosalpinx provided significantly better pain relief compared to lidocaine, normal saline, or no injection, as measured by self-assessment pain intensity scales.

Patients receiving bupivacaine required significantly less supplemental fentanyl for pain management in the post-anesthesia care unit, indicating its effectiveness in reducing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine infiltration of the mesosalpinx in ambulatory surgical laparoscopic tubal sterilization. Alexander, CD., Wetchler, BV., Thompson, RE.[2018]

In a study of 60 elective total knee arthroplasty patients, those who received a bupivacaine injection reported lower pain scores and used fewer narcotics in the first 24 hours post-surgery compared to the placebo group.

Although the bupivacaine group had a shorter discharge time from the postanesthesia care unit by 23 minutes, the differences in pain levels and narcotic consumption were not statistically significant when compared to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine bolus injection versus placebo for pain management following total knee arthroplasty. Browne, C., Copp, S., Reden, L., et al.[2022]

In a study of 27 women undergoing reduction mammaplasty, postoperative injections of bupivacaine significantly reduced the need for morphine, with patients receiving bupivacaine consuming much less morphine compared to those receiving saline.

The effectiveness of bupivacaine in lowering morphine consumption was consistent regardless of whether it was injected into the incision margin or deep into the wound, indicating its analgesic effect is robust across different administration sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent injection of bupivacaine into the margin or the cavity after reduction mammaplasty. Holmgren, RT., Tarpila, E.[2019]

In a double-blind trial involving 50 patients, wound perfusion with 0.5% bupivacaine significantly improved pain relief after surgery compared to saline, as measured by visual analogue scores (VAS).

Patients receiving saline experienced similar pain relief but had higher opioid requirements and no improvement in forced vital capacity (FVC), indicating that bupivacaine may provide better overall analgesia and respiratory function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal wound perfusion for the relief of postoperative pain. Levack, ID., Holmes, JD., Robertson, GS.[2019]

In a study of 19 women undergoing excision biopsy for benign breast lumps, bupivacaine infiltration provided complete postoperative pain relief for 14 participants, demonstrating its efficacy in pain management.

The control group, which received saline instead of bupivacaine, required significantly more opioid analgesia and still experienced inadequate pain relief, highlighting the superior effectiveness of bupivacaine without any reported adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia by wound infiltration after surgical excision of benign breast lumps. Owen, H., Galloway, DJ., Mitchell, KG.[2018]

In a study of 31 patients undergoing breast reduction surgery, those who received a local anesthetic pain pump with bupivacaine reported significantly lower pain scores and used fewer narcotics compared to those who received a saline placebo.

Patients receiving bupivacaine also experienced fewer episodes of postoperative nausea and vomiting, indicating that the local anesthetic not only alleviated pain but also improved overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Rawlani, V., Kryger, ZB., Lu, L., et al.[2021]

In a study involving patients undergoing spinal block anesthesia for chronic pain evaluation, 5 ml of preservative-free normal saline did not significantly alter sensitivity to pinprick in the lower back and legs, indicating it does not have anesthetic effects.

These results contradict previous findings that suggested normal saline could act as a weak local anesthetic, leading to the recommendation of using it as a placebo in spinal block procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal normal saline without preservative does not have a local anesthetic effect. Teeple, E., Scott, DL., Ghia, JN.[2021]

In a study of 98 women undergoing breast reduction surgery, those who received a local anesthetic pain pump with 0.25% bupivacaine reported significantly lower pain scores on the day of surgery and the first two postoperative days compared to those who did not receive the pump.

Patients with the pain pump also used less narcotics and experienced fewer episodes of postoperative nausea and vomiting (PONV), indicating that the pain pump not only alleviates pain but also improves overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Kryger, ZB., Rawlani, V., Lu, L., et al.[2013]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12570905/

Comparing the analgesic efficacy of liposomal bupivacaine ... The primary outcome is the intensity of postoperative pain within 72 hours. Two reviewers will independently screen studies, extract data and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04494880

NCT04494880 | Marcaine Post-Operative Pain Study Study Overview. Brief Summary. The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery.

3. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/10/e108951.full.pdf

Comparing the analgesic efficacy of liposomal bupivacaine ... Introduction Effective management of postoperative pain is essential for enhancing recovery and improving patient satisfaction after breast ...

4. withpower.com withpower.com/trial/bupivacaine-injection-for-postoperative-pain-in-breast-reduction-1b3e6

Bupivacaine Injection for Postoperative Pain in Breast ... In one study, patients who received bupivacaine reported better pain relief compared to those who received saline, and they required less opioid medication ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825001160

Research progress of liposomal bupivacaine and its value ... They observed that patients in the LB group reported significantly lower pain scores at both 24 and 48 h post-surgery compared to those who received ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4012190/

Safety of liposome extended-release bupivacaine for ... Results: Six studies fitted the inclusion criteria for analysis, DepoFoam bupivacaine used in therapeutic doses was well-tolerated, had a higher safety margin, ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2777506

Standard vs Liposomal Bupivacaine for Postoperative Pain ... Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...

8. journals.viamedica.pl journals.viamedica.pl/rpor/article/view/105039

Liposomal bupivacaine and postoperative opioid ... Some studies have demonstrated promising results related to the efficacy of liposomal bupivacaine (LB), a long-acting local analgesic used ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681521006306

Postoperative pain and opioid use after breast reduction ... Here we investigate the effects of erector spinae nerve blocks on postoperative pain, opioid consumption, and quality of life after breast reduction.