- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04606836
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 Contact
- Name: Julianne Sutton, MPH
- Phone Number: 5025620390
- Email: jsutton@klienertkutz.com
Study Locations
-
-
Indiana
-
New Albany, Indiana, United States, 47150
- Recruiting
- Baptist Health Floyd
-
Contact:
- Michelle Palazzo, MD
- Email: mpalazzo@kleinertkutz.com
-
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:
- Michelle Palazzo, MD
- Email: mpalazzo@kleinertkutz.com
-
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:
- Michelle Palazzo, MD
- Email: mpalazzo@kleinertkutz.com
-
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:
- Michelle Palazzo, MD
- Email: mpalazzo@kleinertkutz.com
-
Principal Investigator:
- Michelle Palazzo, MD
-
Sub-Investigator:
- Uzair Qazi, MD
-
Sub-Investigator:
- Rehan Zahid, MD
-
Contact:
- Julianne Sutton, MPH
- Phone Number: 5025620390
- Email: jsutton@kleinertkutz.com
-
Louisville, Kentucky, United States, 40202
- Recruiting
- HCCOC, Jewish Hospital
-
Contact:
- Michelle Palazzo, MD
- Email: mpalazzo@kleinertkutz.com
-
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).
|
See group descriptions
Other Names:
|
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.
Collaborators
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.
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
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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