This study aims to provide high quality evidence from a double-blinded, randomized controlled trial on the efficacy of perioperative pregabalin in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. It hence aims to improve on choice of analgesia adjuncts for total knee arthroplasty.
Aims: Whether pregabalin given preoperatively and for one week postoperatively in addition to patient-controlled analgesia (PCA) morphine is effective in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. Methodology: A single-centre double-blind randomized controlled trial in patients undergoing primary total knee arthroplasty. All subjects receive PCA morphine, paracetamol 1g every six hours, etoricoxib 120mg once daily postoperatively. Subjects receive either pregabalin 75mg po preoperatively followed by 75mg OM and 25mg ON for two days postoperatively or matching placebo. The primary outcome is cumulative morphine consumption at 72 hr following surgery. Secondary outcome measures included pain scores, knee range of motion and patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
Placebo capsule containing lactose and MCC (no active ingredients).
Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore
Cumulative morphine consumption at 72 hours postoperatively
Time frame: 72 hours postoperatively
Functional scores: SF-36v2 at 3 months and 6 months postoperatively
Time frame: 3 months and 6 months postoperatively
Functional scores: Knee Society Score at 3 months and 6 months postoperatively
Time frame: 3 months and 6 months postoperatively
Functional scores: WOMAC at 3 months and 6 months postoperatively
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3 months and 6 months postoperatively
Knee range of motion at 3 months and 6 months postoperatively
Time frame: 3 months and 6 months postoperatively
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Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia
patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3. Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany
Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden