Clinical trial NCT02954484: Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty
Official title: Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative morphine consumption at 72 hours postoperatively
timeFrame: 72 hours postoperatively
Secondary outcomes:
measure: Functional scores: SF-36v2 at 3 months and 6 months postoperatively
timeFrame: 3 months and 6 months postoperatively
measure: Functional scores: Knee Society Score at 3 months and 6 months postoperatively
timeFrame: 3 months and 6 months postoperatively
measure: Functional scores: WOMAC at 3 months and 6 months postoperatively
timeFrame: 3 months and 6 months postoperatively
measure: Knee range of motion at 3 months and 6 months postoperatively
timeFrame: 3 months and 6 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: National University Health System, Singapore
name: lingaraj krishna, frcs (Orth)
role: PRINCIPAL_INVESTIGATOR
References: