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

NCT07117565 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-08-12

No results posted yet for this study

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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Conditions

  • Spinal Anesthesia
  • Postoperative Complications
  • Dexmedetomidine
  • Fentanyl
  • Anesthesia, Spinal
  • Bupivacaine
  • POUR
  • Orthopedic Surgery
  • Urinary 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.

Sponsors & Collaborators

  • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117565 on ClinicalTrials.gov