Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
Overview
- Phase
- Phase 2
- Intervention
- Liposomal Bupivacaine
- Conditions
- Breast Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Primary Endpoint
- total post-operative narcotic utilization
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.
Detailed Description
This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy. OBJECTIVES 1. Compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. Compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block. 2. Examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake. 3. Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled to have a unilateral, immediate breast reconstruction
Exclusion Criteria
- •Concurrent or recent medical condition that could interfere with study participation including:
- •Hepatitis
- •Alcohol/substance abuse
- •Uncontrolled psychiatric disorders
- •Known allergy
- •Contraindication to amide-type local anesthetics, opioids, or propofol.
- •Body weight of less than 50 kg
- •Participated in another study involving an investigational medication within the prior 30 days
- •Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.
Arms & Interventions
Liposomal Bupivacaine + Bupivacaine
This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Liposomal Bupivacaine
Liposomal Bupivacaine + Bupivacaine
This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Bupivacaine
Liposomal Bupivacaine + Bupivacaine
This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Patient-Controlled Analgesia Pump
Liposomal Bupivacaine + Bupivacaine
This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Oral Narcotic
Bupivacaine
This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Bupivacaine
Bupivacaine
This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Patient-Controlled Analgesia Pump
Bupivacaine
This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
Intervention: Oral Narcotic
Outcomes
Primary Outcomes
total post-operative narcotic utilization
Time Frame: Up to 72 hours post-operative
post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.
Secondary Outcomes
- coughing pain score on visual analog scale(Up to 72 hours post-operative)
- number of incidents of nausea reported by patient(Up to 72 hours post-operative)
- time to first ambulation(Up to 72 hours post-operative)
- at rest pain score on visual analog scale(Up to 72 hours post-operative)
- number of incidents of vomiting reported by patient(Up to 72 hours post-operative)
- time to first liquid intake(Up to 72 hours post-operative)
- time to first solid intake(Up to 72 hours post-operative)