ICNBs for Post-op Pain in Breast Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative, Length of Stay

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cases will be recruited prospectively and controls will be taken retrospectively
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Cases<br>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). | Drug: Bupivacaine Hydrochloride<br>* See group descriptions<br>* Other names: Marcaine;|
| No Intervention: Retrospective Controls<br>Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain) | Immediately post-operation | 
| Post-operative pain | Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain) | 30 minutes post-operation | 
| Post-operative pain | Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain) | 60 minutes post-operation | 
| Post-operative pain | Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain) | 120 minutes post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | time of discharge compared with time of surgery completion; Measured in number of days spent in hospital, i.e., 1 day | Through study completion, average of 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICNB, pain