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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
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 βYesβ for the criteria belowSelect...
I am 19 or older and scheduled for kidney stone surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 0 hours post-operatively to 24 hours post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 hours post-operatively to 24 hours post-operatively
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
1,599 Previous Clinical Trials
2,287,834 Total Patients Enrolled
15 Trials studying Pain
6,997 Patients Enrolled for Pain
Mark Mandabach, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 19 or older and scheduled for kidney stone surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid Naive - placebo
- Group 2: Opioid Tolerant - baclofen
- Group 3: Opioid Tolerant - placebo
- Group 4: Opioid Naive - baclofen
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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