Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Patient-Controlled Analgesia Pump; Drug: Oral Narcotic

• Registration Number: NCT03393117
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-08
• Study Start: 2018-03-30
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Patients scheduled to have a unilateral, immediate breast reconstruction

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Exclusion Criteria

• Pregnant

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine + Bupivacaine	Oral Narcotic	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.
Liposomal Bupivacaine + Bupivacaine	Patient-Controlled Analgesia Pump	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.
Liposomal Bupivacaine + Bupivacaine	Liposomal 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.
Bupivacaine	Oral Narcotic	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.
Bupivacaine	Patient-Controlled Analgesia Pump	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.
Liposomal Bupivacaine + 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.
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.

Primary Outcome Measures

Name	Time	Method
total post-operative narcotic utilization	Up to 72 hours post-operative	post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.

Secondary Outcome Measures

Name	Time	Method
coughing pain score on visual analog scale	Up to 72 hours post-operative	0-100 score of self-reported pain
number of incidents of nausea reported by patient	Up to 72 hours post-operative	self-report of nausea
time to first ambulation	Up to 72 hours post-operative
at rest pain score on visual analog scale	Up to 72 hours post-operative	0-100 score of self-reported pain
number of incidents of vomiting reported by patient	Up to 72 hours post-operative	number of times a patient vomits
time to first liquid intake	Up to 72 hours post-operative
time to first solid intake	Up to 72 hours post-operative