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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

September 14, 2026

Study Completion Date

November 25, 2026

Conditions
Spinal AnesthesiaPostoperative ComplicationsDexmedetomidineFentanylAnesthesia, SpinalBupivacainePOUROrthopedic SurgeryUrinary Retention Postoperative
Interventions
DRUG

Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine

"Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine~Detailed Description:~This intervention consists of a single intrathecal injection of 10 micrograms of dexmedetomidine combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anaesthesia for lower limb surgery. The total volume administered is 3.5 mL. Dexmedetomidine is an alpha-2 non-opioid adjuvant used as a spinal adjuvant for enhancing analgesia"

DRUG

Intervention 2: Intrathecal Fentanyl with Bupivacaine

This intervention consists of a single intrathecal injection of 25 micrograms of fentanyl combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anesthesia for lower limb surgery. The total volume administered is 3.5 mL. Fentanyl is a lipophilic opioid commonly used as a spinal adjuvant for enhancing analgesia. This arm is being compared with dexmedetomidine to evaluate differences in POUR incidence, analgesic effectiveness, and side effect profiles.

Trial Locations (1)

57200

Om Sai Pathibhara Hospital, Bhadrapur

All Listed Sponsors
lead

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER