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Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02954484
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: pregabalin Drug: Placebo Drug: Etoricoxib Drug: paracetamol Drug: Morphine Drug: Ropivacaine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial
Study Start Date : April 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: PREGABALIN
All subjects receive intravenous PCA morphine, paracetamol 1g po six hourly and etoricoxib 120mg po once daily. Subjects receive pregabalin 75mg orally preoperatively followed by 75mg at night for two days. During surgery, patients received general anaesthesia with femoral nerve block on the side of surgery.
Drug: pregabalin
see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
Other Name: Lyrica (Pfizer Pte Ltd, Singapore)

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

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

Drug: Morphine

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

Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany


Drug: Ropivacaine
Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden
Other Name: 'Naropin'

Placebo Comparator: PLACEBO
All subjects receive intravenous PCA morphine, paracetamol 1g po six hourly and etoricoxib 120mg po once daily. Subjects receive either placebo tablet (of identical appearance to pregabalin) orally preoperatively followed by 75mg at night for two days. During surgery, patients received general anaesthesia with femoral nerve block on the side of surgery.
Drug: Placebo
Placebo capsule containing lactose and MCC (no active ingredients).
Other Name: Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.

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

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

Drug: Morphine

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

Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany


Drug: Ropivacaine
Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden
Other Name: 'Naropin'




Primary Outcome Measures :
  1. Cumulative morphine consumption at 72 hours postoperatively [ Time Frame: 72 hours postoperatively ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954484


Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: lingaraj krishna, frcs (Orth) National University Health System, Singapore

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02954484     History of Changes
Other Study ID Numbers: 190514
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Acetaminophen
Pregabalin
Etoricoxib
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Analgesics, Non-Narcotic
Antipyretics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs