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Bupivacaine Hydrochloride for Postoperative Pain Control After Skin Surgery

Phase 1

Waitlist Available

Led By Murad Alam, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Receiving cutaneous surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days post-surgery

Awards & highlights

Study Summary

This trial is testing if adding bupivacaine HCl injections to standard care after skin surgery can help improve pain control for patients.

Who is the study for?

This trial is for adults over 18 in good health who are undergoing skin surgery and live in the Chicago area. They must be able to communicate effectively and consent to participate. People can't join if they're pregnant, planning pregnancy, allergic to bupivacaine or similar anesthetics, have issues with narcotics, or have mental impairments.Check my eligibility

What is being tested?

The study tests whether injecting Bupivacaine Hydrochloride after skin surgery provides better pain control than saline injections. Participants will record their pain medication use post-surgery for three days and report back within 7-21 days.See study design

What are the potential side effects?

Bupivacaine may cause side effects like numbness at the injection site, weakness, dizziness, nausea or vomiting. Severe reactions are rare but could include heart problems or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am undergoing skin surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reported opioid and non-opioid pain medications taken

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Bupivacaine HClActive Control1 Intervention

Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.

Group II: SalinePlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,881 Total Patients Enrolled

5 Trials studying Postoperative Pain

297 Patients Enrolled for Postoperative Pain

Murad Alam, MDPrincipal InvestigatorNorthwestern University

69 Previous Clinical Trials

2,480 Total Patients Enrolled

Media Library

Skin Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04260854 — Phase 1

Postoperative Pain Research Study Groups: Bupivacaine HCl, Saline

Postoperative Pain Clinical Trial 2023: Skin Surgery Highlights & Side Effects. Trial Name: NCT04260854 — Phase 1

Skin Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04260854 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation rate of this research trial?

"At this moment, no more patients are being sought for the trial. It was initially advertised on January 1st 2023 and last modified on March 2nd 2022. However, if you are searching for other studies related to pain management or Bupivacaine HCl, there are 483 trials actively recruiting participants in these areas."

Answered by AI

Has Bupivacaine HCl obtained regulatory authorization?

"Our team has deemed Bupivacaine HCl as a 1 on the safety scale, since this is just a Phase 1 trial and there are limited studies available to support its efficacy."

Answered by AI

Are there available vacancies for participants in this research project?

"The clinicaltrials.gov website reveals that this trial has concluded recruitment, having been initially posted on 1/1/2023 and last updated on 3/2/2022. Despite the closure of said study, there are 592 other trials actively seeking patient enrolment at present."

Answered by AI

Could you elucidate on any past explorations regarding Bupivacaine HCl?

"Currently, 109 research studies for Bupivacaine HCl are in progress. 18 of these trials have progressed to Phase 3 and there is a total of 144 different sites where the study can be conducted. The bulk of this medical research takes place in Philadelphia, Pennsylvania."

Answered by AI