ICNBs for Post-op Pain in Breast Surgery

December 7, 2020 updated by: Christine M. Kleinert Institute for Hand and Microsurgery

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Baptist Health Floyd
        • Contact:
        • Principal Investigator:
          • Michelle Palazzo, MD
        • Sub-Investigator:
          • Uzair Qazi, MD
        • Sub-Investigator:
          • Rehan Zahid, MD
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Ambulatory Surgery Center, Kleinert Kutz Hand Care Center
        • Contact:
        • Principal Investigator:
          • Michelle Palazzo, MD
        • Sub-Investigator:
          • Uzair Qazi, MD
        • Sub-Investigator:
          • Rehan Zahid, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Contact:
        • Principal Investigator:
          • Michelle Palazzo, MD
        • Sub-Investigator:
          • Uzair Qazi, MD
        • Sub-Investigator:
          • Rehan Zahid, MD
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Christine M Kleinert Institute for Hand and Microsurgery
        • Contact:
        • Principal Investigator:
          • Michelle Palazzo, MD
        • Sub-Investigator:
          • Uzair Qazi, MD
        • Sub-Investigator:
          • Rehan Zahid, MD
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • HCCOC, Jewish Hospital
        • Contact:
        • Principal Investigator:
          • Michelle Palazzo, MD
        • Sub-Investigator:
          • Uzair Qazi, MD
        • Sub-Investigator:
          • Rehan Zahid, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Bupivacaine Hydrochloride
See group descriptions
Other Names:
  • Marcaine
No Intervention: Retrospective Controls
Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: Immediately 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)
Immediately post-operation
Post-operative pain
Time Frame: 30 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)
30 minutes post-operation
Post-operative pain
Time Frame: 60 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)
60 minutes post-operation
Post-operative pain
Time Frame: 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)
120 minutes post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: 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
Through study completion, average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Collaborators

Kleinert, Kutz and Associates
Jewish Hospital and St. Mary's Healthcare
Baptist Health

Investigators

  • Principal Investigator: Michelle Palazzo, MD, Christine M. Kleinert Institute for Hand and Microsurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.0781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only those researchers involved with the trial will have access to the individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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