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NCT Number: NCT06502262

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.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University

Cairo, Abbassia, 00202, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Hydrochloride

Drug

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

Fentanyl

Drug

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

Dexmedetomidine

Drug

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

Other names: precedex

Primary outcomes

  1. motor blockade onset

    Time frame: from injection up to Modified Bromage score 1 ( 5 minutes)

    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)

  2. sesnory onset

    Time frame: from injection up to s1 regression ( 5 minutes)

    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

  3. post operative analgesia

    Time frame: from injection up to 24 hours post operative

    will be evaluated using a visual analog scale (VAS),

Secondary outcomes

  1. drop in mean blood pressure

    Time frame: from injection up to 24 hours post operative

    using non invasive arterial blood pressure monitoring

  2. drop in oxygen saturation

    Time frame: from injection up to24hours post operative

    using pulse oximiter

  3. drop in heart rate

    Time frame: from injection up to 24 hours post operative

    using ecg monitoring

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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