Marcaine Post-Operative Pain Study

NCT04494880 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 1618426-3
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year

Study Arms (2)

Treatment Group (Marcaine 1 Breast)

EXPERIMENTAL

Marcaine will be injected into one randomized breast and saline into the other in the treatment group.

Drug: Bupivacaine Injection

Control Group (Marcaine 2 Breasts)

NO INTERVENTION

Marcaine will be injected into both breasts as is currently the standard of care.

Interventions

Bupivacaine Injection DRUG

Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.

Also known as: Marcaine

Treatment Group (Marcaine 1 Breast)

Eligibility Criteria

• Age: Up to 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be receiving bilateral breast reduction surgery

You may not qualify if:

• Unilateral breast reduction surgery

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

Upstate University Hospital

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Prashant Upadhyaya, MD

  SUNY Upstate Medical University - Syracuse, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: December 9, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)