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ICNBs for Post-op Pain in Breast Surgery

Primary Purpose

Pain, Postoperative, Length of Stay

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Sponsored by
Christine M. Kleinert Institute for Hand and Microsurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring ICNB, pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ambulatory Surgery Center, Kleinert Kutz Hand Care CenterRecruiting
  • Baptist Health FloydRecruiting
  • Christine M Kleinert Institute for Hand and MicrosurgeryRecruiting
  • HCCOC, Jewish HospitalRecruiting
  • Baptist Health LouisvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective Cases

Retrospective Controls

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2020
Last Updated
December 7, 2020
Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators
Jewish Hospital and St. Mary's Healthcare, Baptist Health, Kleinert, Kutz and Associates
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1. Study Identification

Unique Protocol Identification Number
NCT04606836
Brief Title
ICNBs for Post-op Pain in Breast Surgery
Official Title
Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators
Jewish Hospital and St. Mary's Healthcare, Baptist Health, Kleinert, Kutz and Associates

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Length of Stay
Keywords
ICNB, pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Cases will be recruited prospectively and controls will be taken retrospectively
Masking
ParticipantOutcomes Assessor
Masking Description
The statistician will be masked to the groups the participants fall in (case vs control).
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective Cases
Arm Type
Experimental
Arm Description
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).
Arm Title
Retrospective Controls
Arm Type
No Intervention
Arm Description
Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
Marcaine
Intervention Description
See group descriptions
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Time Frame
Immediately post-operation
Title
Post-operative pain
Description
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Time Frame
30 minutes post-operation
Title
Post-operative pain
Description
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Time Frame
60 minutes post-operation
Title
Post-operative pain
Description
Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)
Time Frame
120 minutes post-operation
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
time of discharge compared with time of surgery completion; Measured in number of days spent in hospital, i.e., 1 day
Time Frame
Through study completion, average of 1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne Sutton, MPH
Phone
5025620390
Email
jsutton@klienertkutz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Organizational Affiliation
Christine M. Kleinert Institute for Hand and Microsurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Surgery Center, Kleinert Kutz Hand Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Email
mpalazzo@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
First Name & Middle Initial & Last Name & Degree
Uzair Qazi, MD
First Name & Middle Initial & Last Name & Degree
Rehan Zahid, MD
Facility Name
Baptist Health Floyd
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Email
mpalazzo@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
First Name & Middle Initial & Last Name & Degree
Uzair Qazi, MD
First Name & Middle Initial & Last Name & Degree
Rehan Zahid, MD
Facility Name
Christine M Kleinert Institute for Hand and Microsurgery
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Email
mpalazzo@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Julianne Sutton, MPH
Phone
5025620390
Email
jsutton@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Uzair Qazi, MD
First Name & Middle Initial & Last Name & Degree
Rehan Zahid, MD
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Facility Name
HCCOC, Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Email
mpalazzo@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Uzair Qazi, MD
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
First Name & Middle Initial & Last Name & Degree
Rehan Zahid, MD
Facility Name
Baptist Health Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
Email
mpalazzo@kleinertkutz.com
First Name & Middle Initial & Last Name & Degree
Michelle Palazzo, MD
First Name & Middle Initial & Last Name & Degree
Uzair Qazi, MD
First Name & Middle Initial & Last Name & Degree
Rehan Zahid, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only those researchers involved with the trial will have access to the individual participant data
Citations:
PubMed Identifier
32629834
Citation
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.
Results Reference
result

Learn more about this trial

ICNBs for Post-op Pain in Breast Surgery

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