CompletedPhase 4

Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty

United States48 participantsStarted 2019-03-22

Plain-language summary

The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery Exclusion Criteria: * Any patient not classified as a II or III on the American Society of Anesthesiologists (ASA) physical status classification system. * General anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques * Allergy/intolerance to local anesthetic or steroids * Pre-existing neurological and/or anatomical deficit that would preclude regional block * Coexisting coagulopathy such as hemophilia or von Willebrand Disease * BMI greater than 40 or less then 20 * History of intravenous drug or opioid abuse * History of opioid use within a week prior to urethroplasty * History of any chronic pain syndrome * Posterior urethroplasty * Patients with chronic kidney disease * Patients allergic to NSAIDs * Patients requiring more than one buccal graft harvest * Patients with graft urethroplasty with site other than buccal * Patients with a history of previous urethroplasty

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participant Pain Control: Numerical Rating Scale (NRS)

Timeframe: 3 weeks

Opioid Medication Use

Timeframe: 3 weeks

Trial details

NCT IDNCT03859024

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

Results submitted2024-08-23

View on ClinicalTrials.gov More Pain, Postoperative trials