Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954484
• Other study ID #: 190514
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2016
• Last updated: September 12, 2017
• Start date: April 2015
• Est. completion date: May 2017

Study information

• Verified date: October 2016
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• pregabalin
see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
• Placebo
Placebo capsule containing lactose and MCC (no active ingredients).
• Etoricoxib
Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore
• paracetamol
Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia
• Morphine
patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3. Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany
• Ropivacaine
Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption at 72 hours postoperatively		72 hours postoperatively
Secondary	Functional scores: SF-36v2 at 3 months and 6 months postoperatively		3 months and 6 months postoperatively
Secondary	Functional scores: Knee Society Score at 3 months and 6 months postoperatively		3 months and 6 months postoperatively
Secondary	Functional scores: WOMAC at 3 months and 6 months postoperatively	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	3 months and 6 months postoperatively
Secondary	Knee range of motion at 3 months and 6 months postoperatively		3 months and 6 months postoperatively