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

NCT06502262 | Completed Phase 1 DMC

• 1 other identifier: MS 571/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• drop in mean blood pressure

  from injection up to 24 hours post operative

• drop in oxygen saturation

  from injection up to24hours post operative

• drop in heart rate

  from injection up to 24 hours post operative

Study Arms (3)

• control

ACTIVE COMPARATOR

• 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

•Fentanyl group

ACTIVE COMPARATOR

•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; Drug: Fentanyl

•Dexmedetomidine group

ACTIVE COMPARATOR

•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; Drug: Dexmedetomidine

Interventions

Bupivacaine Hydrochloride DRUG

patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally.

• control; •Dexmedetomidine group; •Fentanyl group

Fentanyl DRUG

patients will be given 3ml (15mg) of 0.5%hyperbaric bupivacaine +0.5ml (25 microgram) of fentanyl intrathecally

•Fentanyl group

Dexmedetomidine DRUG

patient will receive 3ml (15mg) of .05 hyperbaric bupivacaine 0.5ml(5 microgram) of diluted dexmedetomidine intrathecally

Also known as: precedex

•Dexmedetomidine group

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Fentanyl; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 16, 2024
• Study Start: January 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: September 5, 2024
• Last Updated: February 17, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)