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. \-

Who can participate

Age range18 Years – 60 Years

SexALL

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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

What they're measuring

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.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-14

Contact for this trial

Sujan Dhakal, MBBS,MD

+9779851325896 szndkl44@gmail.com