Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04260854
Collaborator
(none)
100
1
2
13
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: A Randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Department of Dermatology Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier:
NCT04260854
Other Study ID Numbers:
  • STU00211424
First Posted:
Feb 7, 2020
Last Update Posted:
Mar 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022