Pain Management After Breast Reduction
Recruiting in Palo Alto (17 mi)
Overseen byBasel Sharaf, MD, DDS
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Opioids, Antiplatelets, Anticoagulants
Disqualifiers: Chronic pain, Pregnancy, Liver dysfunction, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.
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 use antiplatelet or anticoagulation therapy.
What data supports the effectiveness of the drug for pain management after breast reduction surgery?
Liposomal bupivacaine, a form of bupivacaine that releases the drug slowly over time, has been shown to be a safe and effective pain reliever in breast reconstruction surgeries, potentially reducing the need for opioids and shortening hospital stays. However, the overall evidence is mixed, with some studies suggesting it may not be more effective than standard local anesthetics.
12345Is liposomal bupivacaine safe for pain management after surgery?
Liposomal bupivacaine (EXPAREL) has been shown to be safe for managing pain after various surgeries, including breast augmentation and reconstruction, and has been used safely in both adults and children.
13567How is the drug Liposomal Bupivacaine unique for pain management after breast reduction?
Liposomal Bupivacaine (Exparel) is unique because it provides long-lasting pain relief for up to 72 hours, reducing the need for opioids and potentially shortening hospital stays compared to standard local anesthetics.
13589Eligibility Criteria
This trial is for adult women aged 18-70 with symptomatic macromastia who are scheduled for breast reduction surgery using a specific incision technique. It's not specified who can't join, but typically those with health conditions affecting the study outcome would be excluded.Inclusion Criteria
I am a woman aged 18-70 with large breasts causing symptoms, planning a specific breast reduction surgery.
Exclusion Criteria
I need daily pain medication for chronic pain.
I have had radiation therapy to my chest before.
I cannot have breast reduction due to my medical or surgical history.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either Liposomal Bupivacaine or 0.25% Bupivacaine Hydrochloride during breast reduction surgery
Immediate post-operative period
1 visit (in-person, surgery day)
Follow-up
Participants are monitored for pain scores and opioid use for 72 hours post-operatively
72 hours
Daily monitoring (virtual or in-person)
Extended Follow-up
Participants may be monitored for any long-term effects or complications
2-4 weeks
Participant Groups
The study compares pain control and opioid use after breast reduction surgery between two drugs: Liposomal Bupivacaine (Exparel) and standard Bupivacaine Hydrochloride. Participants will receive one of these medications to manage post-surgery pain.
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Breast Treatment Group: Liposomal (Exparel) BupivacaineExperimental Treatment2 Interventions
Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.
Group II: Control Breast Treatment Group: Bupivacaine HydrochlorideActive Control1 Intervention
Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.
Liposomal Bupivacaine is already approved in United States for the following indications:
🇺🇸 Approved in United States as EXPAREL for:
- Postsurgical local analgesia via infiltration in adults
- Regional analgesia via interscalene brachial plexus nerve block in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic MinnesotaRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]Patients undergoing mastectomy and prosthetic breast reconstruction have significant acute postsurgical pain, routinely mandating inpatient hospitalization. Liposomal bupivacaine (LB) (Exparel; Pacira Pharmaceuticals, Inc., Parsippany, N.J.) has been shown to be a safe and effective pain reliever in the immediate postoperative period and may be advantageous for use in mastectomy and breast reconstruction patients.
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]The authors provide a comprehensive summary of all randomized, controlled trials (n = 76) involving the clinical administration of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, USA) to control postoperative pain that are currently published. When infiltrated surgically and compared with unencapsulated bupivacaine or ropivacaine, only 11% of trials (4 of 36) reported a clinically relevant and statistically significant improvement in the primary outcome favoring liposomal bupivacaine. Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal bupivacaine. Results were mixed for the 16 trials comparing liposomal and unencapsulated bupivacaine, both within peripheral nerve blocks. Overall, of the trials deemed at high risk for bias, 84% (16 of 19) reported statistically significant differences for their primary outcome measure(s) compared with only 14% (4 of 28) of those with a low risk of bias. The preponderance of evidence fails to support the routine use of liposomal bupivacaine over standard local anesthetics.
Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]The long-acting preparation of bupivacaine, liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), was approved by the Food and Drug Administration in October 2011 and has been shown to be safe in breast augmentation. It remains to be established if liposomal bupivacaine provides superior pain control in this setting.
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]Liposomal bupivacaine (LB) is a depot formulation of bupivacaine, which releases the drug over 72 hours to prolong local pain control. This retrospective study compares the effect of using LB versus plain bupivacaine on postoperative pain control, length of hospital stay and cost among patients undergoing vaginal reconstructive surgery.
Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. [2019]Postoperative pain control can be challenging in reduction mammaplasty patients. This study compares perioperative liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, Inc, San Diego, Calif) with standard local anesthetics to determine if liposomal bupivacaine decreases opioid and antiemetic use, impacting length of stay and complication rates, thus improving patient outcomes.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]Liposomal bupivacaine (LB, Exparel) is a long-acting local anesthetic reported to decrease postoperative. The authors demonstrate the first safe use of LB in pediatric patients with improved pain control following pharyngoplasty.
The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial. [2021]Postoperative pain control after abdominally based autologous microvascular breast reconstruction is critical to functional recovery, patient satisfaction, and early discharge. The transversus abdominis plane block using 0.25% bupivacaine hydrochloride has been shown to be effective, but it is limited by a short duration of effect. Liposomal bupivacaine is a recently U.S. Food and Drug Administration-approved preparation of bupivacaine that can provide up to 72 hours of pain relief. The purpose of this randomized, controlled trial was to compare the analgesic efficacy of liposomal bupivacaine and conventional bupivacaine.
Treatment of digital ischemia with liposomal bupivacaine. [2021]Objective. This report describes a case in which the off-label use of liposomal bupivacaine (Exparel) in a peripheral nerve block resulted in marked improvement of a patient's vasoocclusive symptoms. The vasodilating and analgesic properties of liposomal bupivacaine in patients with ischemic symptoms are unknown, but our clinical experience suggests a role in the management of patients suffering from vasoocclusive disease. Case Report. A 45-year-old African American female was admitted to the hospital with severe digital ischemic pain. She was not a candidate for any vascular surgical or procedural interventions. Two continuous supraclavicular nerve blocks were placed with modest clinical improvement. These effects were also short-lived, with the benefits resolving after the discontinuation of the peripheral nerve blocks. She continued to report severe pain and was on multiple anticoagulant medications, so a decision was made to perform an axillary nerve block using liposomal bupivacaine (Exparel) given the compressibility of the site as well as the superficial nature of the target structures. Conclusions. This case report describes the successful off-label usage of liposomal bupivacaine (Exparel) in a patient with digital ischemia. Liposomal bupivacaine (Exparel) is currently FDA approved only for wound infiltration use at this time.