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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
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.
Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.
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.
Time frame: 96 hours
Average Post-operative Length of Stay
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
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
Time frame: 24hours, 48 hours and 72 hours post-surgery
Post-operative Urinary Catheterisation Rates
% of patients requiring catheterisation for urinary retention post-surgery
Time frame: 72 hours 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
Time frame: 24hours, 48 hours and 72 hours post-surgery
Day of Ambulation
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
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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)
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
Time frame: one week prior to surgery, 6 weeks post-surgery , one year post-surgery
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
Time frame: 30 days and one year post-surgery