Wall, Peter D. H., Sprowson, Andrew P., Parsons, Nicholas R., Parsons, Helen, Achten, Juul, Balasubramanian, S. and Costa, Matthew L. (2015) Protocol for a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus single-agent femoral nerve blockade as analgesia for total knee arthroplasty: Perioperative Analgesia for Knee Arthroplasty (PAKA). BMJ Open, 5 (12). e009898. doi:10.1136/bmjopen-2015-009898

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Abstract

Introduction: Total knee arthroplasty (TKA) surgery causes postoperative pain. The use of perioperative injections around the knee containing local anaesthetic, opiates and non-steroidal anti-inflammatory drugs has increased in popularity to manage pain. Theoretical advantages include reduced requirements for analgesia and earlier mobilisation. We propose a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus femoral nerve anaesthetic blockade as analgesia for TKA. The aim is to determine, in patients undergoing TKA, if there is a difference in patient-reported pain scores on the visual analogue scale (VAS) prior to physiotherapy on day 1 postoperatively between treatment groups.

Methods and analysis: Patients undergoing a primary unilateral TKA at University Hospitals Coventry and Warwickshire Hospitals will be assessed for eligibility. A total of 264 patients will provide 90% power to detect a difference of 12 mm on the VAS on day 1 postoperatively at the 5% level. The trial will use 1:1 randomisation, stratified by mode of anaesthetic. Primary outcome measure will be the VAS for pain prior to physiotherapy on day 1. Secondary outcome measures include VAS on day 2, total use of opiate analgesia up to 48 h, ordinal pain scores up to 40 min after surgery, independent functional knee physiotherapist assessment on days 1 and 2. Oxford knee Scores (OKS), EuroQol (EQ-5D) and Douleur Neuropathic Pain Scores (DN2) will be recorded at baseline, 6 weeks and 12 months. Adverse events will be recorded up to 12 months. Analysis will investigate differences in VAS on day 1 between the two treatment groups on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are less than 0.05.

Ethics and dissemination: NRES Committee West Midlands, 23 September 2013 (ref: 13/WM/0316). The results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration numbers: ISRCTN 60611146 and EUDRACT Number 2013-002439-10 (protocol code number PAKA-33601-AS117013); Pre-results.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Arthroplasty, Anesthesia, Analgesia, Knee -- Surgery, Total knee replacement , Nonsteroidal anti-inflammatory agents, Anti-inflammatory agents
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	21 December 2015
Dates:	Date Event 21 December 2015 Published 13 October 2015 Accepted 2 September 2015 Submitted
Date of first compliant deposit:	7 January 2016
Volume:	5
Number:	12
Article Number:	e009898
DOI:	10.1136/bmjopen-2015-009898
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	National Institute for Health Research (Great Britain) (NIHR)
Grant number:	PB-PG-0212-27098
Adapted As:
Contributors:	Contribution Name Contributor ID Research Group Perioperative Analgesia for Knee Arthroplasty (PAKA) collaborato, PAKA UNSPECIFIED

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