Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ICNBs for Post-op Pain in Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04606836
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborators:
Jewish Hospital and St. Mary's Healthcare
Baptist Health
Kleinert, Kutz and Associates
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Length of Stay Drug: Bupivacaine Hydrochloride Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cases will be recruited prospectively and controls will be taken retrospectively
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The statistician will be masked to the groups the participants fall in (case vs control).
Primary Purpose: Prevention
Official Title: Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Marcaine
No Intervention: Retrospective Controls
Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606836


Contacts
Layout table for location contacts
Contact: Julianne Sutton, MPH 5025620390 jsutton@klienertkutz.com

Locations
Layout table for location information
United States, Indiana
Ambulatory Surgery Center, Kleinert Kutz Hand Care Center Recruiting
New Albany, Indiana, United States, 47150
Contact: Michelle Palazzo, MD       mpalazzo@kleinertkutz.com   
Principal Investigator: Michelle Palazzo, MD         
Sub-Investigator: Uzair Qazi, MD         
Sub-Investigator: Rehan Zahid, MD         
Baptist Health Floyd Recruiting
New Albany, Indiana, United States, 47150
Contact: Michelle Palazzo, MD       mpalazzo@kleinertkutz.com   
Principal Investigator: Michelle Palazzo, MD         
Sub-Investigator: Uzair Qazi, MD         
Sub-Investigator: Rehan Zahid, MD         
United States, Kentucky
Christine M Kleinert Institute for Hand and Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Michelle Palazzo, MD       mpalazzo@kleinertkutz.com   
Contact: Julianne Sutton, MPH    5025620390    jsutton@kleinertkutz.com   
Sub-Investigator: Uzair Qazi, MD         
Sub-Investigator: Rehan Zahid, MD         
Principal Investigator: Michelle Palazzo, MD         
HCCOC, Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Michelle Palazzo, MD       mpalazzo@kleinertkutz.com   
Sub-Investigator: Uzair Qazi, MD         
Principal Investigator: Michelle Palazzo, MD         
Sub-Investigator: Rehan Zahid, MD         
Baptist Health Louisville Recruiting
Louisville, Kentucky, United States, 40207
Contact: Michelle Palazzo, MD       mpalazzo@kleinertkutz.com   
Principal Investigator: Michelle Palazzo, MD         
Sub-Investigator: Uzair Qazi, MD         
Sub-Investigator: Rehan Zahid, MD         
Sponsors and Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
Jewish Hospital and St. Mary's Healthcare
Baptist Health
Kleinert, Kutz and Associates
Investigators
Layout table for investigator information
Principal Investigator: Michelle Palazzo, MD Christine M. Kleinert Institute for Hand and Microsurgery
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT04606836    
Other Study ID Numbers: 20.0781
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only those researchers involved with the trial will have access to the individual participant data

Layout table for additional information
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
Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
ICNB
pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents