Intra-operative pain relief for patients following a total knee replacement.

Perioperative Analgesia for Knee Arthroplasty: A prospective randomised controlled trial - PAKA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002439-10-GB

Enrollment

264

Registered

2013-10-18

Start date

2013-10-23

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee is a common problem

Interventions

Product Name: Ketorolac Trometamol Product Code: PAMMIX Pharmaceutical Form: Powder for injection INN or Proposed INN: Ketorolac trometamol CAS Number: 74103-07-04 Current Sponsor code: ketorolac Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients undergoing an elective primary unilateral total knee arthroplasty under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: A concomitant medical or psychiatric problem which, in the opinion of hte Investigator, would prevent completion of treatment or follow-up; patients with a pre-operative history neurological abnormality in the ipsilateral leg; patients with specific contraindication to the analgesia agents use; participation in a clinical trial of an investigational medicinal product in the last 90 days; previous entry in the present trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to determine if there a difference in patient reported pain prior to physiotherapy on the first post operative day between patients managed with local knee injections (peri-articular),compared to the standard treatment (femoral nerve block),following a total knee replacement. ;Secondary Objective: The secondary aim is to assess the function and health outcome of the intervention group at 6 weeks post operation. ;Primary end point(s): The primary outcome measure for this study is pain on day one post-operatively, assessed using a 100mm visual analgue scale (VAS). VAS provides an accurate objective value for pain perceived by the patient, this scale is of most value when looking at change within individuals. ;Timepoint(s) of evaluation of this end point: The VAS taken on day one post operatively is the primary outcome measure. It will also be taken day two post operatively	—

Measure

Time frame

Main Objective: The aim of this study is to determine if there a difference in patient reported pain prior to physiotherapy on the first post operative day between patients managed with local knee injections (peri-articular),compared to the standard treatment (femoral nerve block),following a total knee replacement. ;Secondary Objective: The secondary aim is to assess the function and health outcome of the intervention group at 6 weeks post operation. ;Primary end point(s): The primary outcome measure for this study is pain on day one post-operatively, assessed using a 100mm visual analgue scale (VAS). VAS provides an accurate objective value for pain perceived by the patient, this scale is of most value when looking at change within individuals. ;Timepoint(s) of evaluation of this end point: The VAS taken on day one post operatively is the primary outcome measure. It will also be taken day two post operatively

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Secondary

Measure	Time frame
Secondary end point(s): A functional patient reported knee score - the oxford knee score. A general patient reported quality of life score - the EQ-5D A battery of standard physiotherapy assessment.;Timepoint(s) of evaluation of this end point: the physio assessment will take place on day 1 and 2 post operatively. The Oxford knee score and EQ-5D will be taken at baseline and 6 weeks post-operatively.	—

Measure

Time frame

Secondary end point(s): A functional patient reported knee score - the oxford knee score. A general patient reported quality of life score - the EQ-5D A battery of standard physiotherapy assessment.;Timepoint(s) of evaluation of this end point: the physio assessment will take place on day 1 and 2 post operatively. The Oxford knee score and EQ-5D will be taken at baseline and 6 weeks post-operatively.

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Countries

United Kingdom

Contacts

Public ContactDr Juul Achten

University of Warwick

J.Achten@warwick.ac.uk02476968614

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026