This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. We'll compare the efficacy of pregabalin between two groups, pregabalin group and control group on the basis of their opioid consumption after knee operation.
After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively. Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically. Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml \& dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement. for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Bahrain Defence Force
Manama, Bahrain
RECRUITINGVisual Analogue Scale Score (0-10)
visual analogue scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. minimum score mean good outcome
Time frame: 72 hours
Richmond Agitation Sedation Scale score {(+4) -0- (-5)}
Richmond Agitation Sedation Scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. score +/-1 to 0 means good outcome.
Time frame: 72 hours
Visual Analogue Sedation score at 1st Continuous Passive Movement
visual analogue score at 1st continuous passive movement
Time frame: with in 24 hours
Time of 1st analgesia request
Estimation of time for 1st complaint of pain
Time frame: within 24 hours
Incident of bradycardia
Incident of reduction in Heart rate in 1st 24 Hours
Time frame: within 24hours
Incident of Hypotension
Incident of reduced blood pressure below baseline
Time frame: within 24 hours
Total opioid consumption
Total opioid consumption in 72hours: Oxycodone/Morphine
Time frame: within 72 hours
Patient satisfaction
Patient satisfaction at 72 hours: rated as numeric 1-5 (1=not satisfied, 5=fully satisfied)
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Time frame: within 72 hours