Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty

Christine M. Kleinert Institute for Hand and Microsurgery5 sites in 1 country40 target enrollmentDecember 7, 2020

ConditionsPain, Postoperative Length of Stay

InterventionsBupivacaine Hydrochloride

DrugsBupivacaine Hydrochloride

Overview

Phase: Phase 4
Intervention: Bupivacaine Hydrochloride
Conditions: Pain, Postoperative
Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Enrollment: 40
Locations: 5
Primary Endpoint: Post-operative pain
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.

Registry

clinicaltrials.gov

Start Date

December 7, 2020

End Date

August 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•American Society of Anesthesiologists Classification (ASA Class) 3 and below.
•Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (\<200 gm), breast augmentation and breast reduction, etc.

Exclusion Criteria

•Patients who refuse local anesthesia.
•Patients who cannot receive local anesthesia.
•Below the age of 20 and above the age of
•Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
•Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety disorders.

Arms & Interventions

Prospective Cases

These cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s).

Intervention: Bupivacaine Hydrochloride