ICNBs for Post-op Pain in Breast Surgery

Phase 4

• Conditions: Pain, Postoperative; Length of Stay
• Interventions: Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04606836
• Lead Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-28
• Status Verified: 2020-12
• Study Start: 2020-12-07
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09
• Primary Completion: 2021-04
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 70.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Cases	Bupivacaine Hydrochloride	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).

Primary Outcome Measures

Name	Time	Method
Post-operative pain	120 minutes post-operation	Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Through study completion, average of 1 day	time of discharge compared with time of surgery completion; Measured in number of days spent in hospital, i.e., 1 day

Trial Locations

Locations (5)

Christine M Kleinert Institute for Hand and Microsurgery; 🇺🇸 Louisville, Kentucky, United States

Ambulatory Surgery Center, Kleinert Kutz Hand Care Center; 🇺🇸 New Albany, Indiana, United States

Baptist Health Floyd; 🇺🇸 New Albany, Indiana, United States

HCCOC, Jewish Hospital; 🇺🇸 Louisville, Kentucky, United States

Baptist Health Louisville; 🇺🇸 Louisville, Kentucky, United States