Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Phase 1

• Conditions: Pain, Postoperative
• Interventions: Drug: Saline; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04260854
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2024-01-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. >18 years of age
2. Receiving cutaneous surgery
3. In good general health as assessed by the investigator

Exclusion Criteria

1. Participants with an allergy to bupivacaine or other amide anesthetics
2. Participants unwilling to sign an IRB approved consent form
3. Participants with a contraindication to narcotic medication
4. Participants who are pregnant or will become pregnant
5. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.
Bupivacaine HCl	Bupivacaine Hydrochloride	Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.

Primary Outcome Measures

Name	Time	Method
Reported opioid and non-opioid pain medications taken	3 Days Post-Surgery	Patients will report the amount of pain medications taken 3 days immediately following surgery

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States