Bupivacaine Injection for Postoperative Pain in Breast Reduction
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byChristopher Hughes, MD, MPH
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Connecticut Children's Medical Center
Must not be taking: Narcotics
Disqualifiers: Substance use disorder, Chronic pain, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
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 20cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 20cc 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.
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.
12345Is 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.
13567How 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.
12389Eligibility Criteria
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.
+1 more
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.
+6 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study Group 1 - InterventionExperimental Treatment1 Intervention
Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia
Group II: Study Group 2 - ControlPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Connecticut Children'sFarmington, CT
Connecticut Children'sHartford, CT
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Who Is Running the Clinical Trial?
Connecticut Children's Medical CenterLead Sponsor
References
Intermittent injection of bupivacaine into the margin or the cavity after reduction mammaplasty. [2019]Twenty-seven operated women had postoperative intermittent injections of bupivacaine or saline for 24 hours after reduction mammaplasty. The injections were given five-hourly either subcutaneously along the submammary incision or deep into the wound. The patients were randomised into three groups of nine each: 5 ml bupivacaine 0.25% into the margin; 5 ml bupivacaine 0.25% into the cavity; and 5 ml physiological saline into the cavity. Postoperatively all patients received oral paracetamol and dextropropoxyphene. If additional analgesia was needed morphine was given intravenously. Total morphine consumption was significantly (p
Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]Breast reduction is one of the most frequently performed plastic surgical procedures in the United States; more than 160,500 patients underwent the procedure in 2005. Many outpatient reduction mammaplasty patients report the greatest postoperative discomfort in the first 48 hours. The authors' investigated the effect of intraoperative topical application of the long-acting local anesthetic agent bupivacaine (Sensorcaine or Marcaine) on postoperative pain, time to postanesthesia care unit discharge, and postoperative use of narcotic medication.
Analgesia by wound infiltration after surgical excision of benign breast lumps. [2018]Wound infiltration with bupivacaine provided complete postoperative pain relief in 14 of 19 women undergoing excision biopsy of a benign breast lump under general anaesthesia. Fifteen patients formed a control group in whom the wound was infiltrated with saline. They had inadequate relief of pain despite receiving significantly more opioid analgesia than the bupivacaine group in the postoperative period. The analgesia from bupivacaine usually outlasted the postoperative pain. No adverse reactions were apparent.
A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. [2021]The purpose of this study was to conduct a double-blind, randomized, prospective trial evaluating the efficacy of a local anesthetic pain pump in reducing postoperative pain, narcotic use, and the incidence of postoperative nausea and vomiting in breast reduction surgery.
Abdominal wound perfusion for the relief of postoperative pain. [2019]In a double-blind trial, 50 patients with subcostal incisions performed for cholecystectomy or splenectomy, received 10 ml of either 0.5% bupivacaine plain or physiological saline twice daily by wound perfusion through an indwelling drainage tube for 3 days after operation. Analgesia, assessed by visual analogue score (VAS) and forced vital capacity (FVC), was significantly improved after perfusion with bupivacaine. Perfusion with physiological saline produced an analgesic effect comparable to that of bupivacaine as indicated by improvement in VAS. There was, however, no improvement in FVC, and opioid requirements were greater, in the patients whose wounds had been perfused with saline.
Intrathecal normal saline without preservative does not have a local anesthetic effect. [2021]The effects of intrathecally administered normal saline (preservative-free) were studied in patients undergoing differential spinal block anesthesia for evaluation of chronic pain below the waist. The injection of 5 ml saline did not significantly change the sensitivity to pinprick measured in the lower back and both lower extremities. Temperature measurement in both the lower extremities and psychogalvanic skin reflex did not show evidence of sympathetic block; the psychogalvanic skin reflex was abandoned because of inconsistent results. These findings refute the earlier conclusion of Urban and McKain who found that normal saline acts as a weak local anesthetic when injected intrathecally. We recommend use of normal saline (preservative-free) in 5 ml doses as a placebo for differential spinal block anesthesia.
Bupivacaine bolus injection versus placebo for pain management following total knee arthroplasty. [2022]Following surgery, total knee arthroplasty (TKA) patients experience considerable pain. All available effective analgesia agents produce some unwanted side effects. Sixty consenting elective TKA patients were randomized to receive bupivacaine 20 mL 0.5% (100 mg) or 20 mL normal saline injected into the joint space after capsule closure. Patients were interviewed up to 24 hours after surgery for pain and pain relief. Narcotic usage was recorded. The bupivacaine group had lower pain scores and reduced narcotics during the 24-hour period, with a 23-minute shorter time to discharge from the postanesthesia care unit than the placebo group (P =.02). Although a bupivacaine bolus injected at capsule closure results in decreased pain levels (P =.07) and narcotic consumption (P =.09), it is not statistically significantly better than placebo.
Bupivacaine infiltration of the mesosalpinx in ambulatory surgical laparoscopic tubal sterilization. [2018]Bupivacaine infiltration of the mesosalpinx was compared to lidocaine, normal saline or no injection for pain relief in women having elective laparoscopic tubal sterilization by Yoon fallopian ring application. One hundred women were assigned randomly to four groups. In a double-blind study, the mesosalpinx was infiltrated in three groups: Group 1 - lidocaine one per cent; Group II - bupivacaine 0.5 per cent; Group III - normal saline. Group IV (control) received no injection. Pain intensity was reported at four study times by the patients on a self-assessment pain intensity scale. Responses were compared using the Kruskall-Wallis H-Test and Wilcoxen's Rank-Sum Test. Both tests indicated significant differences in pain intensity levels at various study times. The amount of supplemental fentanyl given was used as a secondary measure of effectiveness. One-way analysis of variance (ANOVA) and Duncan's Multiple-Range Test showed the bupivacaine group to receive significantly less fentanyl (p less than 0.05) in the postanaesthesia care unit.
Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. [2013]The purpose of this study was to conduct a prospective trial evaluating the efficacy of a local anesthetic pain pump in breast reduction surgery. Ninety-eight women undergoing bilateral breast reduction were enrolled. Thirty-seven patients received a pain pump containing 0.25% bupivicaine, and 61 patients received no pain pump. Parameters measured included subjective pain, episodes of postoperative nausea and vomiting (PONV), and the amount of narcotics and antiemetics used. Patients receiving a pain pump reported significantly lower pain scores on the day of surgery, as well as on the first and second postoperative days when compared with patients who did not (P