Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

NCT02954484 | Completed Phase 3 DMC

• 1 other identifier: 190514
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Cumulative morphine consumption at 72 hours postoperatively

  72 hours postoperatively

Secondary Outcomes (4)

• 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

• Knee range of motion at 3 months and 6 months postoperatively

  3 months and 6 months postoperatively

Study Arms (2)

PREGABALIN

ACTIVE COMPARATOR

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; Drug: Etoricoxib; Drug: paracetamol; Drug: Morphine; Drug: Ropivacaine

PLACEBO

PLACEBO COMPARATOR

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; Drug: Etoricoxib; Drug: paracetamol; Drug: Morphine; Drug: Ropivacaine

Interventions

pregabalin DRUG

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

Also known as: Lyrica (Pfizer Pte Ltd, Singapore)

PREGABALIN

Placebo DRUG

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

Also known as: Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.

PLACEBO

Etoricoxib DRUG

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

Also known as: 'Arcoxia'

PLACEBO; PREGABALIN

paracetamol DRUG

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

Also known as: acetaminophen

PLACEBO; PREGABALIN

Morphine DRUG

patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3. Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany

PLACEBO; PREGABALIN

Ropivacaine DRUG

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

Also known as: 'Naropin'

PLACEBO; PREGABALIN

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing primary total knee arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Etoricoxib; Acetaminophen; Morphine; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• lingaraj krishna, frcs (Orth)

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: November 3, 2016
• Study Start: April 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share