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Non-Opioid Analgesic

Bupivacaine for Urethral Stricture

Phase 4
Waitlist Available
Led By John P Selph, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Study Summary

This trial will test if a different way of giving pain medication before and during surgery can decrease the risk of opioid addiction and improve pain control.

Eligible Conditions
  • Urethral Stricture
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid medication use
Participant pain control: Numerical Rating Scale (NRS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Recovery ProtocolExperimental Treatment7 Interventions
A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed.
Group II: Standard ProtocolActive Control3 Interventions
Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550
Bupivacaine
2013
Completed Phase 4
~1530
Dexamethasone
2007
Completed Phase 4
~2590
Acetaminophen
2017
Completed Phase 4
~2030
Ibuprofen 800 mg
2007
Completed Phase 4
~1040
celebrex
2019
Completed Phase 4
~1440
Oxycodone
2014
Completed Phase 4
~2210

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,586 Previous Clinical Trials
2,280,172 Total Patients Enrolled
John P Selph, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

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

What medical applications does Bupivacaine commonly serve?

"Bupivacaine is a viable treatment option for macular edema, pemphigus and ocular disorders."

Answered by AI

Are there any existing investigations into the efficacy of Bupivacaine?

"Currently, 202 Phase 3 trials are actively exploring the effects of Bupivacaine on patients. The research is conducted at 818 facilities across 20738 locations, with a considerable concentration in Mishawaka Indiana."

Answered by AI

Are there any vacancies available for involvement in the clinical trial?

"Affirmative. Per clinicaltrials.gov, this medical trial remains active and open to applicants; the initial posting date was March 22nd 2019 with a recent update on March 16th 2022. The goal is to enlist 60 patients at one facility."

Answered by AI

How many individuals have enrolled in the experiment to date?

"Indeed, the information on clinicialtrials.gov affirms that this trial is still actively recruiting patients. It was initially published on March 22nd 2019 and last modified on March 16th 2022. The study requires 60 participants from 1 medical centre to take part in it."

Answered by AI

What potential health risks are associated with the utilization of Bupivacaine?

"Due to the fact that it is a Phase 4 trial and has thus been approved, Bupivacaine was awarded an evaluation of 3 on our safety scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Adam Baumgarten 2019. "Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03859024.
~10 spots leftby Apr 2025
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