ICNBs for Post-op Pain in Breast Surgery

NCT04606836 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 20.0781
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain, Postoperative; Length of Stay

Keywords

ICNB; pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Length of Hospital Stay

  Through study completion, average of 1 day

Study Arms (2)

Prospective Cases

EXPERIMENTAL

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

Retrospective Controls

NO INTERVENTION

Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.

Interventions

Bupivacaine Hydrochloride DRUG

See group descriptions

Also known as: Marcaine

Prospective Cases

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christine M. Kleinert Institute for Hand and Microsurgery: lead
• Jewish Hospital and St. Mary's Healthcare: collaborator
• Baptist Health: collaborator
• Kleinert, Kutz and Associates: collaborator

Study Sites (5)

Ambulatory Surgery Center, Kleinert Kutz Hand Care Center

New Albany, Indiana, 47150, United States

RECRUITING

Baptist Health Floyd

New Albany, Indiana, 47150, United States

RECRUITING

Christine M Kleinert Institute for Hand and Microsurgery

Louisville, Kentucky, 40202, United States

RECRUITING

HCCOC, Jewish Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

RECRUITING

Related 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):325. doi: 10.3390/medicina56070325.

  PMID: 32629834 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michelle Palazzo, MD

  Christine M. Kleinert Institute for Hand and Microsurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julianne Sutton, MPH

CONTACT

5025620390; jsutton@klienertkutz.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician will be masked to the groups the participants fall in (case vs control).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cases will be recruited prospectively and controls will be taken retrospectively

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 28, 2020
• Study Start: December 7, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)