Pregabalin
Drugsee arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
Other names: Lyrica (Pfizer Pte Ltd, Singapore)
NCT Number: NCT02954484
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.
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Notify Me21 year–90 year
All sexes
Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
Other names: Lyrica (Pfizer Pte Ltd, Singapore)
Placebo capsule containing lactose and MCC (no active ingredients).
Other names: Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.
Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore
Other names: 'Arcoxia'
Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia
Other names: acetaminophen
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
Other names: 'Naropin'
Time frame: 72 hours postoperatively
Time frame: 3 months and 6 months postoperatively
Time frame: 3 months and 6 months postoperatively
Time frame: 3 months and 6 months postoperatively
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3 months and 6 months postoperatively
National University Hospital, Singapore
Other
Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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