A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Po… (NCT06502262) | Clinical Trial Compass
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 range
21 Years – 55 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
motor blockade onset
Timeframe: from injection up to Modified Bromage score 1 ( 5 minutes)
2
sesnory onset
Timeframe: from injection up to s1 regression ( 5 minutes)
3
post operative analgesia
Timeframe: from injection up to 24 hours post operative