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Baclofen for Post-Surgical Pain

Phase 4
Recruiting
Led By Mark Mandabach, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 hours post-operatively to 24 hours post-operatively
Awards & highlights

Study Summary

This trial will test whether a common muscle relaxer can help reduce painkiller use after surgery.

Who is the study for?
This trial is for adults aged 19 or older who are scheduled for kidney stone surgery. It's not suitable for those allergic to baclofen or with conditions that could affect their ability to report and manage post-surgery pain, such as severe psychiatric disorders or language barriers.Check my eligibility
What is being tested?
The study is testing if a single oral dose of baclofen (10mg) can reduce the need for opioids after surgery. Participants will either receive baclofen or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Baclofen may cause side effects like drowsiness, weakness, dizziness, headache, seizures, nausea, and confusion. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 19 or older and scheduled for kidney stone surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 hours post-operatively to 24 hours post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 hours post-operatively to 24 hours post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Opioid Requirements

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Opioid Tolerant - baclofenExperimental Treatment1 Intervention
Group II: Opioid Naive - baclofenExperimental Treatment1 Intervention
Group III: Opioid Naive - placeboPlacebo Group1 Intervention
Group IV: Opioid Tolerant - placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baclofen
FDA approved

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,226 Total Patients Enrolled
15 Trials studying Pain
7,007 Patients Enrolled for Pain
Mark Mandabach, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Baclofen 10mg Clinical Trial Eligibility Overview. Trial Name: NCT03720717 — Phase 4
Pain Research Study Groups: Opioid Naive - placebo, Opioid Tolerant - baclofen, Opioid Tolerant - placebo, Opioid Naive - baclofen
Pain Clinical Trial 2023: Baclofen 10mg Highlights & Side Effects. Trial Name: NCT03720717 — Phase 4
Baclofen 10mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03720717 — Phase 4

Frequently Asked Questions

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

Has there been prior experimentation involving the administration of Baclofen 10mg?

"At present, 4 investigations into Baclofen 10mg are running. Three of these studies have advanced to Phase 3 trials and there are a total of 88 sites participating in the research spread across Birmingham, Alabama."

Answered by AI

To what extent could ingesting Baclofen 10mg pose a threat to health?

"The safety of Baclofen 10mg has been assessed and given a rating of 3, as it is currently approved for use in phase 4 trials."

Answered by AI

How many individuals are participating in the research protocol?

"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants and has been since October 17th 2019. The most recent update was posted on September 12th 2022 and the project requires 86 volunteers from 1 location."

Answered by AI

Does this experiment still accept new participants?

"Affirmative. According to clinicaltrials.gov, the study is currently running and recruiting participants; it was initially posted on October 17th 2019 and last modified on September 12th 2022. 86 individuals must be sourced from a single site in order for the trial to properly progress."

Answered by AI

What are the approved indications for Baclofen 10mg?

"Baclofen 10mg is a powerful analgesic often used to ameliorate conditions such as spinal cord injuries, myalgia and multiple sclerosis."

Answered by AI
~16 spots leftby Apr 2025