ICNBs for Post-op Pain in Breast Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04606836
• Other study ID #: 20.0781
• Status: Recruiting
• Phase: Phase 4
• Start date: December 7, 2020
• Est. completion date: August 2021

Study information

• Verified date: December 2020
• Source: Christine M. Kleinert Institute for Hand and Microsurgery
• Contact: Julianne Sutton, MPH
• Phone: 5025620390
• Email: jsutton[@]klienertkutz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Length of Stay
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine Hydrochloride
See group descriptions

Locations

Country	Name	City	State
United States	Baptist Health Louisville	Louisville	Kentucky
United States	Christine M Kleinert Institute for Hand and Microsurgery	Louisville	Kentucky
United States	HCCOC, Jewish Hospital	Louisville	Kentucky
United States	Ambulatory Surgery Center, Kleinert Kutz Hand Care Center	New Albany	Indiana
United States	Baptist Health Floyd	New Albany	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Christine M. Kleinert Institute for Hand and Microsurgery	Baptist Health, Jewish Hospital and St. Mary's Healthcare, Kleinert, Kutz and Associates

Country where clinical trial is conducted

United States, 

References & Publications (1)

Park JW, Kim JH, Woo KJ. Intraoperative Intercostal Nerve Block for Postoperative Pain Control in Pre-Pectoral versus Subpectoral Direct-to-Implant Breast Reconstruction: A Retrospective Study. Medicina (Kaunas). 2020 Jun 30;56(7). pii: E325. doi: 10.3390 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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