NCT06502262

A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia.

Detailed description

The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia. All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anesthesia and maintenance volume of 10ml\\kg. For each group, patients will be put in sitting position, lumbar puncture will be performed under complete aseptic precautions, local anesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used. * Group 1: (Control group) (20 cases): patients will receive 3 ml (15mg) of 0.5% hyperbaric bupivacaine+0.5 ml of normal saline intrathecally. * Group 2: (Fentanyl group) (20 cases): patients will receive 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (25μg) of fentanyl intrathecally. * Group 3: (Dexmedetomidine group) (20 cases): patients will receive 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride	patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally.
DRUG	Fentanyl	patients will be given 3ml (15mg) of 0.5%hyperbaric bupivacaine +0.5ml (25 microgram) of fentanyl intrathecally
DRUG	Dexmedetomidine	patient will receive 3ml (15mg) of .05 hyperbaric bupivacaine 0.5ml(5 microgram) of diluted dexmedetomidine intrathecally

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-08-15
• Completion: 2024-09-05
• First posted: 2024-07-16
• Last updated: 2025-02-17

Locations

1 site across 1 country: Egypt