NCT04260854

Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: a Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the addition of bupivacaine HCl injections will improve pain control after skin surgery. This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride	Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
DRUG	Saline	Normal saline injections.

Timeline

• Start date: 2024-01-24
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2020-02-07
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study