Back to resultsMarcaine Post-Operative Pain Study
Primary Purpose
Effect of Drug
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Effect of Drug
Eligibility Criteria
Inclusion Criteria:
- Must be receiving bilateral breast reduction surgery
Exclusion Criteria:
- Unilateral breast reduction surgery
Sites / Locations
- Upstate University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group (Marcaine 1 Breast)
Control Group (Marcaine 2 Breasts)
Arm Description
Marcaine will be injected into one randomized breast and saline into the other in the treatment group.
Marcaine will be injected into both breasts as is currently the standard of care.
Outcomes
Primary Outcome Measures
Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes
Secondary Outcome Measures
Full Information
NCT ID
NCT04494880
First Posted
July 28, 2020
Last Updated
May 9, 2022
Sponsor
State University of New York - Upstate Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04494880
Brief Title
Marcaine Post-Operative Pain Study
Official Title
Marcaine Post-Operative Pain Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University
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
5. Study Description
Brief Summary
The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery. Patients who consent will be randomized to which breast receives a Marcaine injection and the other breast will have saline injected. Pain will be assessed one time post-operatively using a 1-10 pain scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group (Marcaine 1 Breast)
Arm Type
Experimental
Arm Description
Marcaine will be injected into one randomized breast and saline into the other in the treatment group.
Arm Title
Control Group (Marcaine 2 Breasts)
Arm Type
No Intervention
Arm Description
Marcaine will be injected into both breasts as is currently the standard of care.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Other Intervention Name(s)
Marcaine
Intervention Description
Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.
Primary Outcome Measure Information:
Title
Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
Description
Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be receiving bilateral breast reduction surgery
Exclusion Criteria:
Unilateral breast reduction surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashant Upadhyaya, MD
Organizational Affiliation
SUNY Upstate Medical University - Syracuse, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Upstate University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Marcaine Post-Operative Pain Study
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