Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03393117
• Other study ID #: CASE10117
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 30, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Mastodynia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at rest pain score on visual analog scale	0-100 score of self-reported pain	Up to 72 hours post-operative
Secondary	coughing pain score on visual analog scale	0-100 score of self-reported pain	Up to 72 hours post-operative
Secondary	number of incidents of nausea reported by patient	self-report of nausea	Up to 72 hours post-operative
Secondary	number of incidents of vomiting reported by patient	number of times a patient vomits	Up to 72 hours post-operative
Secondary	time to first ambulation		Up to 72 hours post-operative
Secondary	time to first liquid intake		Up to 72 hours post-operative
Secondary	time to first solid intake		Up to 72 hours post-operative