NCT07522736

Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery

The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.

Detailed description

Intrathecal adjuncts are commonly added to local anesthetic agents, to improve the duration of nerve blocks and postoperative pain relief without increasing the dosage of local anesthetic. Studies have shown that dexmedetomidine (DEX) has a greater potential for enhancing analgesic effects due to its higher specificity for alpha2 adrenoceptors. DEX is commonly used for sedation and as an adjunct to reduce the amount of anesthesia and opioids required during general and regional anesthesia in both adults and children.

Conditions

• Intrathecal Dexmedetomidine
• Bupivacaine
• Knee Orthopedic Surgery

Interventions

Type	Name	Description
DRUG	Dexmedetomidine 4 μg	Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.
DRUG	Dexmedetomidine 8 μg	Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.
DRUG	Dexmedetomidine 12 μg	Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Egypt