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NCT Number: NCT02954484

Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

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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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.

Other names: Lyrica (Pfizer Pte Ltd, Singapore)

Placebo

Drug

Placebo capsule containing lactose and MCC (no active ingredients).

Other names: Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.

Etoricoxib

Drug

Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore

Other names: 'Arcoxia'

Paracetamol

Drug

Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia

Other names: acetaminophen

Morphine

Drug

patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3.

Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany

Ropivacaine

Drug

Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden

Other names: 'Naropin'

Primary outcomes

  1. Cumulative morphine consumption at 72 hours postoperatively

    Time frame: 72 hours postoperatively

Secondary outcomes

  1. Functional scores: SF-36v2 at 3 months and 6 months postoperatively

    Time frame: 3 months and 6 months postoperatively

  2. Functional scores: Knee Society Score at 3 months and 6 months postoperatively

    Time frame: 3 months and 6 months postoperatively

  3. Functional scores: WOMAC at 3 months and 6 months postoperatively

    Time frame: 3 months and 6 months postoperatively

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  4. Knee range of motion at 3 months and 6 months postoperatively

    Time frame: 3 months and 6 months postoperatively

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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