Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

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

Status

Enrolling by invitation

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04260854

Enrollment

100

Registered

2020-02-07

Start date

2024-01-24

Completion date

2028-12-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGBupivacaine Hydrochloride

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

DRUGSaline

Normal saline injections.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMurad Alam, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026