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Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Controlled Epidural (PCEA)
Local Infiltration Analgesia (LIA)
Sponsored by
Golden Jubilee National Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring local infiltration analgesia, Epidural, Enhanced Recovery, Total Knee Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients (age> 18years old) undergoing primary unilateral total knee arthroplasty (TKA) with a clinical diagnosis of osteoarthritis

Exclusion Criteria:

  • Patients planned for uni-compartmental/bilateral or revision knee surgery patients
  • Patients with a diagnosis of rheumatoid arthritis (RA)
  • Patients with coagulation or anatomical defects e.g. preventing the use of spinal anaesthesia
  • Known allergies to any medications within the trial
  • Patients who were unable to give written informed consent
  • Patients requiring pre-operative catheterisation for urinary outflow dysfunction
  • Known neurological incident that would limit or make impossible early ambulation following surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Patient Controlled Epidural (PCEA)

    Local Infiltration Analgesia (LIA)

    Arm Description

    A lumbar epidural was sited using a side-directed technique towards the side of surgery following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes to control their pain until the following morning (post-operative day one) when it was stopped. Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).

    Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.

    Outcomes

    Primary Outcome Measures

    Proportion of Patients Discharged From Rehabilitation by Day Four
    % of patients meeting predetermined discharge criteria at 96 Hours post-surgery. The discharge criteria were: self dependent (dress, personal care); in and out of bedd independently; up and down stairs; walk with crutches/stick; 80 degrees knee flexion; able to straight leg raise operated limb.

    Secondary Outcome Measures

    Average Post-operative Length of Stay
    Participants will be followed for the duration of hospital stay, an expected average of 5 days
    Verbal Rating Score (VRS) Pain Scores
    Summary 24 hour Verbal rated numerical pain scores were gathered each day. Scale range 0-10 where 0 is no pain and 10 is worst imaginable pain
    Post-operative Urinary Catheterisation Rates
    % of patients requiring catheterisation for urinary retention post-surgery
    Post-operative Nausea and Vomiting Scores
    percentage of patients reporting either symptoms of nausea or vomiting over the first 72 hours following surgery. Scale 0-2 wherein 0=no nausea and vomiting, 1=nausea and 2= nausea and vomiting
    Day of Ambulation
    Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres
    Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation
    Patient Reported Outcome Measure - Oxford Knee Score
    Units measured on old Oxford Score (12-60) from a 12 point questionnaire. Where in 60 is poor and lower scores are better patient reported outcome scores
    Total Number of Reported Participants With Complications and/or Adverse Events
    The composite number of adverse events reported per group at 30 days and then one year post surgery

    Full Information

    First Posted
    April 2, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Golden Jubilee National Hospital
    Collaborators
    Glasgow Caledonian University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02478372
    Brief Title
    Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty
    Official Title
    Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty Within an Enhanced Recovery Programme - a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    November 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Golden Jubilee National Hospital
    Collaborators
    Glasgow Caledonian University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to determine if the method of peri-operative analgesia used following total Knee Replacement surgery affected the progress towards rehabilitation goals and to determine whether the analgesia had any impact on long term outcomes.
    Detailed Description
    Enhanced Recovery Programmes (ERP) as defined by Henrik Kehlet have been established within orthopaedics within the United Kingdom in a number of centres (Malviya et al., 2011, McDonald et al., 2012, Scott et al., 2013) demonstrating improvements in patient outcomes. However as the ERP involved in all of these papers are a redesign of a number of key elements of the clinical pathway it remains unclear as to the level of significance each component may have on the patient's reported outcomes. The use of Local Infiltration Analgesia (LIA) as the primary post-operative analgesic technique has grown in popularity in Scotland over the past 5 years (Scott et al., 2013). A number of large cohort series have concurrently reported significant improvements in early ambulation and shortened lengths of stay (Malviya et al., 2011, McDonald et al., 2012) yet it remains unclear as to whether this is due to the introduction and use of the LIA technique or the overall development of the ERP programmes. The aim of this parallel group randomised controlled trial was to test two different methods of regional analgesia (LIA and Epidural) and their impact on attainment of predetermined rehabilitation criteria for direct discharge home and to consider the impact of each technique on long term functional status up to one year post surgery. Epidural analgesia when utilised as post-operative analgesia is predominantly used in the format of a continuous infusion of a set volume of analgesia (+/- adjuncts such as fentanyl) resulting in both a motor and sensory blockade, which as would be expected increases with the volume infused. Ambulatory patient epidurals have been used for a number of years within maternity services which provide adequate pain relief whilst enabling the patient to be mobile (Stewart & Fernando, 2011). Therefore to provide a fairer comparison with the LIA technique the standard epidural analgesia technique within the Golden Jubilee National Hospital was adapted to a Patient Controlled Epidural Analgesia (PCEA) system with no background infusion. The planned long term follow up period ( One year) was developed to enable greater evidence of the impact of each method on functional capacity, Patient Reported Outcome Scores (PROMS) and to monitor the incidence of adverse incidents over a longer period of time than previously published literature.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis
    Keywords
    local infiltration analgesia, Epidural, Enhanced Recovery, Total Knee Arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    242 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient Controlled Epidural (PCEA)
    Arm Type
    Active Comparator
    Arm Description
    A lumbar epidural was sited using a side-directed technique towards the side of surgery following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes to control their pain until the following morning (post-operative day one) when it was stopped. Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
    Arm Title
    Local Infiltration Analgesia (LIA)
    Arm Type
    Experimental
    Arm Description
    Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.
    Intervention Type
    Drug
    Intervention Name(s)
    Patient Controlled Epidural (PCEA)
    Other Intervention Name(s)
    Levobupivacaine and Bupivacaine
    Intervention Description
    Following the operation, 4ml of 0.25% levobupivacaine was administered and the catheter was connected to a PCEA. Self-medication with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one) when it was stopped.
    Intervention Type
    Drug
    Intervention Name(s)
    Local Infiltration Analgesia (LIA)
    Other Intervention Name(s)
    Ropivacaine
    Intervention Description
    Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.
    Primary Outcome Measure Information:
    Title
    Proportion of Patients Discharged From Rehabilitation by Day Four
    Description
    % of patients meeting predetermined discharge criteria at 96 Hours post-surgery. The discharge criteria were: self dependent (dress, personal care); in and out of bedd independently; up and down stairs; walk with crutches/stick; 80 degrees knee flexion; able to straight leg raise operated limb.
    Time Frame
    96 hours
    Secondary Outcome Measure Information:
    Title
    Average Post-operative Length of Stay
    Description
    Participants will be followed for the duration of hospital stay, an expected average of 5 days
    Time Frame
    Average number of days spent in hospital follwoing surgery, an expected average of 5 days
    Title
    Verbal Rating Score (VRS) Pain Scores
    Description
    Summary 24 hour Verbal rated numerical pain scores were gathered each day. Scale range 0-10 where 0 is no pain and 10 is worst imaginable pain
    Time Frame
    24hours, 48 hours and 72 hours post-surgery
    Title
    Post-operative Urinary Catheterisation Rates
    Description
    % of patients requiring catheterisation for urinary retention post-surgery
    Time Frame
    72 hours post-surgery
    Title
    Post-operative Nausea and Vomiting Scores
    Description
    percentage of patients reporting either symptoms of nausea or vomiting over the first 72 hours following surgery. Scale 0-2 wherein 0=no nausea and vomiting, 1=nausea and 2= nausea and vomiting
    Time Frame
    24hours, 48 hours and 72 hours post-surgery
    Title
    Day of Ambulation
    Description
    Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres
    Time Frame
    theatre day, day 1 post-surgery, day two post-surgery
    Title
    Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation
    Time Frame
    On day of discharge from rehabilitation in-patient care (average 96 hours post surgery)
    Title
    Patient Reported Outcome Measure - Oxford Knee Score
    Description
    Units measured on old Oxford Score (12-60) from a 12 point questionnaire. Where in 60 is poor and lower scores are better patient reported outcome scores
    Time Frame
    one week prior to surgery, 6 weeks post-surgery , one year post-surgery
    Title
    Total Number of Reported Participants With Complications and/or Adverse Events
    Description
    The composite number of adverse events reported per group at 30 days and then one year post surgery
    Time Frame
    30 days and one year post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All patients (age> 18years old) undergoing primary unilateral total knee arthroplasty (TKA) with a clinical diagnosis of osteoarthritis Exclusion Criteria: Patients planned for uni-compartmental/bilateral or revision knee surgery patients Patients with a diagnosis of rheumatoid arthritis (RA) Patients with coagulation or anatomical defects e.g. preventing the use of spinal anaesthesia Known allergies to any medications within the trial Patients who were unable to give written informed consent Patients requiring pre-operative catheterisation for urinary outflow dysfunction Known neurological incident that would limit or make impossible early ambulation following surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David A McDonald, BSc
    Organizational Affiliation
    Golden Jubilee National Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty

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