Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

NCT04260854 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: STU00211424
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Reported opioid and non-opioid pain medications taken

  Patients will report the amount of pain medications taken 3 days immediately following surgery

  3 Days Post-Surgery

Study Arms (2)

Bupivacaine HCl

ACTIVE COMPARATOR

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

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Bupivacaine Hydrochloride DRUG

Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.

Bupivacaine HCl

Saline DRUG

Normal saline injections.

Saline

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Receiving cutaneous surgery
• In good general health as assessed by the investigator

You may not qualify if:

• Participants with an allergy to bupivacaine or other amide anesthetics
• Participants unwilling to sign an IRB approved consent form
• Participants with a contraindication to narcotic medication
• Participants who are pregnant or will become pregnant
• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 7, 2020
• Study Start: January 24, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)