Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04260854
• Other study ID #: STU00211424
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: January 24, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• Saline
Normal saline injections.

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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