Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

NCT ID: NCT03393117

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2020-07-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type: DRUG

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.

Bupivacaine

Intervention Type: DRUG

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.

Patient-Controlled Analgesia Pump

Intervention Type: DRUG

The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.

Oral Narcotic

Intervention Type: DRUG

Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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.

Patient-Controlled Analgesia Pump

Intervention Type: DRUG

The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.

Oral Narcotic

Intervention Type: DRUG

Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Oral Narcotic

Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.

Intervention Type: DRUG

Other Intervention Names

Exparel; Sensorcaine-Methyl Paraben Free (MPF) Spinal; Sensorcaine-MPF; Sensorcaine; ReadySharp Bupivacaine; P-Care M; Marcaine Spinal; Marcaine Preservative Free; Marcaine; Bupivacaine Spinal; intravenous narcotic

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Risal Djohan, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Other Identifiers

CASE10117

Identifier Type: -

Identifier Source: org_study_id