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Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

NCT03393117 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-07-22

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

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.

DRUG

Oral Narcotic

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Risal Djohan, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2020-07-01
Completion
2020-07-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393117 on ClinicalTrials.gov