Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Withdrawn; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Patient-Controlled Analgesia Pump; Drug: Bupivacaine; Drug: Oral Narcotic; Drug: Liposomal Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03393117

CASE10117

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Liposomal Bupivacaine + Bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal Bupivacaine

Drug: Oral Narcotic

Drug: Patient-Controlled Analgesia Pump

Drug: Bupivacaine

Bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Oral Narcotic

Drug: Patient-Controlled Analgesia Pump

Drug: Bupivacaine