A Phase 4 interventional study of Pregabalin 75mg and adductor canal block in Postoperative Pain, sponsored by Bahrain Defence Force Hospital. Recruiting at 1 site in Bahrain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Bahrain Defence Force Hospital · Phase 4, Interventional, and Treatment
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 120 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Bahrain Defence Force Hospital as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
Drug: Pregabalin 75mg · Procedure: adductor canal block
This group of patient will not receive cap pregabalin but it will receive standard medical care as routine
Procedure: adductor canal block
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
Also known as: capsule
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Also known as: peripheral nerve block
Visual 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)
Time frame: within 72 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We're still formulating the extended contact plan to follow patients for chronic pain.
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Studies of the drug tested here: Pregabalin