Clinical trial NCT03393117: Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction
Official title: Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Reconstruction
Bupivacaine
Liposomal Bupivacaine
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to have a unilateral, immediate breast reconstruction

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.

Primary outcomes:
measure: total post-operative narcotic utilization
timeFrame: Up to 72 hours post-operative
Secondary outcomes:
measure: at rest pain score on visual analog scale
timeFrame: Up to 72 hours post-operative
measure: coughing pain score on visual analog scale
timeFrame: Up to 72 hours post-operative
measure: number of incidents of nausea reported by patient
timeFrame: Up to 72 hours post-operative
measure: number of incidents of vomiting reported by patient
timeFrame: Up to 72 hours post-operative
measure: time to first ambulation
timeFrame: Up to 72 hours post-operative
measure: time to first liquid intake
timeFrame: Up to 72 hours post-operative
measure: time to first solid intake
timeFrame: Up to 72 hours post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Risal Djohan, MD
role: PRINCIPAL_INVESTIGATOR
References: