Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Northwestern University

Status and phase: Invitation-only; Phase 1

Conditions: Pain, Postoperative

Treatments: Drug: Saline; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04260854

STU00211424

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Bupivacaine HCl

Active Comparator group

Description:

Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.

Treatment:

Drug: Bupivacaine Hydrochloride

Saline

Placebo Comparator group

Description:

Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.

Treatment:

Drug: Saline