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Dexmedetomidine vs Fentanyl in Erector Spinae Plane Block for Nephrectomy

NCT06799442Phase 3

Key facts

Status: Not yet recruiting
Start: Mar 2025
Primary completion: Dec 2025
Countries: 1
Sponsor: Assiut University
Modality: Small Molecules

Drugs: dexmedetomidine
Conditions: postoperative pain

Overview

Phase 3, randomised, double-blind trial of dexmedetomidine in postoperative pain (2 arms), sponsored by Assiut University. Primary endpoint: Time to first analgesic request at 24 hours. Planned start Mar 2025; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Group dexmedetomidine
Bupivacaine 0.25% + 50 mic dexmedetomidine
Group fentanyl
Bupivacaine 0.25% + 100 mic fentanyl

Who it enrols

Adult patients undergoing simple nephrectomy with ASA class I (or II implied). Excludes BMI >= 40, chronic opioid use, spine deformities, local infection, and neuropsychiatric disorders.

Endpoints

Primary

Time to first analgesic request24 hours

Secondary

Numerical Rating Scale (NRS) Pain Scores24 hours
Total opioid dose in the first 24 hours24 hours
Duration of analgesia24 hours
Incidence of Postoperative nausea & vomiting24 hours
Intraoperative and Postoperative Hemodynamics24 hours

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