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?

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.

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.

Is bupivacaine safe for use in humans?

Bupivacaine has been used safely in various surgical procedures, including breast surgeries and knee replacements, without apparent adverse reactions. It is generally considered safe for managing postoperative pain in humans. ^{1 2 3 4 5}

How does the drug saline differ from other treatments for postoperative pain in breast reduction?

Saline, when used for postoperative pain in breast reduction, serves as a control treatment and does not provide the same pain relief as bupivacaine, a local anesthetic that significantly reduces pain and the need for additional pain medication. ^{4 5 6 7 8}

What data supports the effectiveness of the drug Marcaine (Bupivacaine) for reducing postoperative pain in breast reduction surgery?

Research shows that using bupivacaine (Marcaine) during breast reduction surgery can significantly reduce postoperative pain and the need for additional pain medication. In one study, patients who received bupivacaine reported better pain relief compared to those who received saline, and they required less opioid medication after surgery. ^{3 4 5 7 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 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 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]

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 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 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 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 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 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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Intermittent injection of bupivacaine into the margin or the cavity after reduction mammaplasty. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Analgesia by wound infiltration after surgical excision of benign breast lumps. [2018]

4. United States 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Abdominal wound perfusion for the relief of postoperative pain. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intrathecal normal saline without preservative does not have a local anesthetic effect. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine bolus injection versus placebo for pain management following total knee arthroplasty. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine infiltration of the mesosalpinx in ambulatory surgical laparoscopic tubal sterilization. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. [2013]