CompletedPhase 1

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

Egypt60 participantsStarted 2024-01-15

Plain-language 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.

Who can participate

Age range21 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

motor blockade onset

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

sesnory onset

Timeframe: from injection up to s1 regression ( 5 minutes)

post operative analgesia

Timeframe: from injection up to 24 hours post operative

Trial details

NCT IDNCT06502262

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-15

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