None listed
Conditions
Brief summary
OBJECTIVE: this study aim to determine efficacy and safety of perioperative Oral pregabalin in improving postoperative pain control in patients undergoing total knee replacement surgeries under regional anaesthesia. HYPOTHESIS: Pregabalin reduces postoperative pain, analgesia and opioid requirement, MATERIAL AND METHODS: STUDY TYPE: Interventional (clinical trial) STUDY SETTING: Operation Theatres, Bahrain defence forces DURATION OF STUDY: 12-18 months after the approval of synopsis SAMPLING TECHNIQUE: Non probability conservative sampling OFFICIAL TITLE: Effect of Perioperative oral pregabalin in Total Knee replacement for postoperative pain. A randomized Controlled Single blind trial. SAMPLE SIZE: sample size of 120 cases (60 in each group) is calculated with 80% power of test, 5% level of significance and taking expected percentage of Pain scores in both groups.
Interventions
120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregablain 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. To ensure adherence to the intervention, empty drug blister will be returned to pharmacy.
Intraoperatively both groups will receive Inj. midazolam 2mg before subarachno
120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregablain 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. To ensure adherence to the intervention, empty drug blister will be returned to pharmacy. Intraoperatively both groups will receive Inj. midazolam 2mg 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 group will receive Ultrasound guided Adductor canal Femoral Nerve block in the PACU with 0.2% Bupivacaine & dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hrly from the 1st dose for next 60 hrs. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hrly for 24 hrs. Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine S/C 4-5mg, in escalating manner as per patient requirement.
Sponsors
Bahrain defence forces hospital, royal medical services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 21 to 85 year 2. Elective Regional anesthesia. 3. Able to follow study protocol
Exclusion criteria
1.ASA -IV 2.Age <18 & > 85 years 3.Patients on pregabalin for chronic neuropathic pain. 4.Patient under General anesthesia 5.Patients with chronic liver failure 6.Patients with chronic renal failure on Hemodialysis 7. Patients on opioid (>3 month) 8. Patient with complicated knee surgery.
Outcome results
None listed