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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Fentanyl; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 00202
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • ASA I or ASA II patients Scheduled for pott's, of either sex.

  • Age 21-55 years.
  • Height 160 to 190 cm.
  • BMI ≤40.
  • Procedure duration ≤ 90 minutes

Exclusion Criteria:

• • Patients with known neurologic and psychiatric illness.

  • Contraindications for spinal anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
  • Spine abnormalities.
  • Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
  • Allergy to any of the drugs used in the study.
  • Women with pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: • control; • Drug: hyperbaric bupivacaine this group will be given 3 ml (15mg) of 0.5% hyperbaric bupivacaine+0.5 ml of normal saline intrathecally.	Drug: Bupivacaine Hydrochloride; patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally.
Active Comparator: •Fentanyl group; •Drug: Fentanyl this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (25μg) of fentanyl intrathecally.	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
Active Comparator: •Dexmedetomidine group; •this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally	Drug: Bupivacaine Hydrochloride; patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally.; Drug: Dexmedetomidine; patient will receive 3ml (15mg) of .05 hyperbaric bupivacaine 0.5ml(5 microgram) of diluted dexmedetomidine intrathecally; Other Names: precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motor blockade onset	Onset of motor block (defined as time in minutes from the end of drug injection intrathecally until patient is unable to move the hip, knee, and ankle)	from injection up to Modified Bromage score 1 ( 5 minutes)
sesnory onset	defined as time in minutes to reach highest sensory level) will be tested every minute after intrathecal injection until it reach the highest level. It will be assessed by pin prick and cold application	from injection up to s1 regression ( 5 minutes)
post operative analgesia	will be evaluated using a visual analog scale (VAS),	from injection up to 24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
drop in mean blood pressure	using non invasive arterial blood pressure monitoring	from injection up to 24 hours post operative
drop in oxygen saturation	using pulse oximiter	from injection up to24hours post operative
drop in heart rate	using ecg monitoring	from injection up to 24 hours post operative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Bupivacaine; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: MS 571/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No