Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

January 29, 2025 updated by: Murad Alam, Northwestern University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine HCl
Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.
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.
Placebo Comparator: Saline
Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.
Drug: Saline
Normal saline injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported opioid and non-opioid pain medications taken
Time Frame: 3 Days Post-Surgery
Patients will report the amount of pain medications taken 3 days immediately following surgery
3 Days Post-Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00211424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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