Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT04260854
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

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.
  • Saline — DRUG
    Normal saline injections.

Study Details

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.

Key Dates

Start date
Jan 24, 2024
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: Saline
    Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.

Primary Outcome Measure

Reported opioid and non-opioid pain medications taken [ Time Frame: 3 Days Post-Surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Department of DermatologyChicagoIllinois60611-

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Northwestern University Department of Dermatology· Chicago, IL

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