Post Operative Pain
Conditions
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.
Interventions
DRUGBupivacaine Hydrochloride
patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally.
DRUGFentanyl
patients will be given 3ml (15mg) of 0.5%hyperbaric bupivacaine +0.5ml (25 microgram) of fentanyl intrathecally
DRUGDexmedetomidine
patient will receive 3ml (15mg) of .05 hyperbaric bupivacaine 0.5ml(5 microgram) of diluted dexmedetomidine intrathecally
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| drop in mean blood pressure | from injection up to 24 hours post operative | using non invasive arterial blood pressure monitoring |
| 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 |
Countries
Egypt
Outcome results
None listed