Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Placebo capsule containing lactose and MCC (no active ingredients).
DRUGpregabalin
see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
DRUGEtoricoxib
Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore
DRUGparacetamol
Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia
DRUGMorphine
patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3. Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany
DRUGRopivacaine
Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing primary total knee arthroplasty
Exclusion criteria
* revision or bilateral arthroplasty, significant renal or hepatic impairment, documented allergy or intolerance to NSAIDs, paracetamol, morphine or pregabalin, chronic pain syndrome treated with chronic opioids, obstructive sleep apnea not treated with continuous positive airway pressure, seizures, breastfeeding, inability to use patient-controlled analgesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative morphine consumption at 72 hours postoperatively | 72 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional scores: SF-36v2 at 3 months and 6 months postoperatively | 3 months and 6 months postoperatively | — |
| Functional scores: Knee Society Score at 3 months and 6 months postoperatively | 3 months and 6 months postoperatively | — |
| Functional scores: WOMAC at 3 months and 6 months postoperatively | 3 months and 6 months postoperatively | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
| Knee range of motion at 3 months and 6 months postoperatively | 3 months and 6 months postoperatively | — |
Outcome results
None listed