drugset / Trial / NCT07117565

D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinary Retention

NCT07117565 ↗

Phase 4 Not yet recruiting 190 enrolled Tribhuvan University Teaching Hospital, Institute Of Medicine.
RandomizedParallel-groupTriple-blindPrevention

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. \-

Timeline

Start
2025-09-15
Primary completion
2026-09-14
Completion
2026-11-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 10 ug Intrathecal
Comparator Fentanyl Other / unclassified 25 ug Intrathecal
Comparator Bupivacaine Other / unclassified 15 mg Intrathecal