Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

NCT ID: NCT02954484

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-05-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

pregabalin

Intervention Type: DRUG

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

Etoricoxib

Intervention Type: DRUG

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

paracetamol

Intervention Type: DRUG

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

Morphine

Intervention Type: DRUG

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

Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany

Ropivacaine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Etoricoxib

Intervention Type: DRUG

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

paracetamol

Intervention Type: DRUG

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

Morphine

Intervention Type: DRUG

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

Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany

Ropivacaine

Intervention Type: DRUG

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

Interventions

pregabalin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Etoricoxib

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

Intervention Type: DRUG

paracetamol

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

Intervention Type: DRUG

Morphine

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

Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany

Intervention Type: DRUG

Ropivacaine

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

Intervention Type: DRUG

Other Intervention Names

Lyrica (Pfizer Pte Ltd, Singapore); Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.; 'Arcoxia'; acetaminophen; 'Naropin'

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lingaraj krishna, frcs (Orth)

Role: PRINCIPAL_INVESTIGATOR

National University Health System, Singapore

Other Identifiers

190514

Identifier Type: -

Identifier Source: org_study_id