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

NCT ID: NCT06502262

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-09-05

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

• control

• Drug: hyperbaric bupivacaine this group will be given 3 ml (15mg) of 0.5% hyperbaric bupivacaine+0.5 ml of normal saline intrathecally.

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

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

•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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

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

Fentanyl

Intervention Type: DRUG

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

•Dexmedetomidine group

•this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

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

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Bupivacaine Hydrochloride

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

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

precedex

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University

Cairo, Abbassia, Egypt

Countries

Egypt

Other Identifiers

MS 571/2023

Identifier Type: -

Identifier Source: org_study_id