A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture
- Conditions
- Post Operative Pain
- Interventions
- Registration Number
- NCT06502262
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
-
• 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
-
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description • control Bupivacaine Hydrochloride • Drug: hyperbaric bupivacaine this group will be given 3 ml (15mg) of 0.5% hyperbaric bupivacaine+0.5 ml of normal saline intrathecally. •Fentanyl group Bupivacaine Hydrochloride •Drug: Fentanyl this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (25μg) of fentanyl intrathecally. •Dexmedetomidine group Bupivacaine Hydrochloride •this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally •Fentanyl group Fentanyl •Drug: Fentanyl this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (25μg) of fentanyl intrathecally. •Dexmedetomidine group Dexmedetomidine •this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally
- Primary Outcome Measures
Name Time Method motor blockade onset 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)
sesnory onset 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
post operative analgesia from injection up to 24 hours post operative will be evaluated using a visual analog scale (VAS),
- Secondary Outcome Measures
Name Time Method drop in oxygen saturation from injection up to24hours post operative using pulse oximiter
drop in heart rate from injection up to 24 hours post operative using ecg monitoring
drop in mean blood pressure from injection up to 24 hours post operative using non invasive arterial blood pressure monitoring
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Abbassia, Egypt