Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Patient-Controlled Analgesia Pump; Drug: Oral Narcotic

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Liposomal Bupivacaine; 20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.; Other Names: Exparel; Drug: Bupivacaine; 20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.; Other Names: Marcaine; Sensorcaine; Marcaine Spinal; Sensorcaine-MPF; P-Care M; Sensorcaine-Methyl Paraben Free (MPF) Spinal; ReadySharp Bupivacaine; Marcaine Preservative Free; Bupivacaine Spinal; Drug: Patient-Controlled Analgesia Pump; The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.; Other Names: intravenous narcotic; Drug: Oral Narcotic; Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
Active Comparator: 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.	Drug: Bupivacaine; 20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.; Other Names: Marcaine; Sensorcaine; Marcaine Spinal; Sensorcaine-MPF; P-Care M; Sensorcaine-Methyl Paraben Free (MPF) Spinal; ReadySharp Bupivacaine; Marcaine Preservative Free; Bupivacaine Spinal; Drug: Patient-Controlled Analgesia Pump; The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.; Other Names: intravenous narcotic; Drug: Oral Narcotic; Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total post-operative narcotic utilization	post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.	Up to 72 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
at rest pain score on visual analog scale	0-100 score of self-reported pain	Up to 72 hours post-operative
coughing pain score on visual analog scale	0-100 score of self-reported pain	Up to 72 hours post-operative
number of incidents of nausea reported by patient	self-report of nausea	Up to 72 hours post-operative
number of incidents of vomiting reported by patient	number of times a patient vomits	Up to 72 hours post-operative
time to first ambulation		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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Risal Djohan, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Reconstruction; Bupivacaine; Liposomal Bupivacaine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Narcotics
• Other Study ID Numbers: CASE10117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No