D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinar… (NCT07117565) | Clinical Trial Compass
Not Yet RecruitingPhase 4
D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinary Retention
Nepal190 participantsStarted 2025-09-15
Plain-language summary
This study aims to compare two medications, dexmedetomidine and fentanyl, when used alongside a commonly used spinal anesthetic called bupivacaine in patients undergoing lower limb surgery. The main focus of the study is to see which combination causes fewer problems with urination after surgery - a condition known as postoperative urinary retention (POUR). POUR can lead to discomfort, delayed recovery, and a need for catheterization. Dexmedetomidine is a newer drug that may help reduce this problem compared to fentanyl, which is more commonly used but may increase the risk of urinary retention. This trial will help determine which medication combination provides better pain relief while reducing urinary side effects. The study is being conducted as a randomized, double-blind trial at a hospital in Nepal and will include 190 adult patients.
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Who can participate
Age range
18 Years – 60 Years
Sex
ALL
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:
* Adults aged 18 to 60 years
* Scheduled for elective lower limb surgery under spinal anesthesia
* Classified as American Society of Anesthesiologists (ASA) physical status II or III
* Minimum height of 150 cm (to ensure uniform drug volume)
* Able to understand the study procedures and provide written informed consent (in English or Nepali)
Exclusion Criteria:
* Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site, hemodynamic instability)
* Known allergy or hypersensitivity to bupivacaine, fentanyl, or dexmedetomidine
* Chronic pain conditions or long-term opioid use
* Neurological, Cardiac, Renal, or uncontrolled diabetic conditions
* Current treatment for prostatic pathology or use of alpha-2 blockers
* Presence of a Foley's catheter preoperatively
* Estimated surgical duration: \>2.5 hours
* Inability or unwillingness to provide informed consent
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
1
Incidence of Postoperative Urinary Retention (POUR) at the 3rd Postoperative Hour
Timeframe: 3 hours after spinal anesthesia
Trial details
NCT IDNCT07117565
SponsorTribhuvan University Teaching Hospital, Institute Of Medicine.