Osteoarthritis
Conditions
Keywords
local infiltration analgesia, Epidural, Enhanced Recovery, Total Knee Arthroplasty
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.
Interventions
DRUGPatient Controlled Epidural (PCEA)
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.
Sponsors
Glasgow Caledonian University
Golden Jubilee National Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Discharged From Rehabilitation by Day Four | 96 hours | % 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
| Measure | Time frame | Description |
|---|---|---|
| Verbal Rating Score (VRS) Pain Scores | 24hours, 48 hours and 72 hours post-surgery | 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 | 72 hours post-surgery | % of patients requiring catheterisation for urinary retention post-surgery |
| Post-operative Nausea and Vomiting Scores | 24hours, 48 hours and 72 hours post-surgery | 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 |
| Average Post-operative Length of Stay | Average number of days spent in hospital follwoing surgery, an expected average of 5 days | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation | On day of discharge from rehabilitation in-patient care (average 96 hours post surgery) | — |
| Patient Reported Outcome Measure - Oxford Knee Score | one week prior to surgery, 6 weeks post-surgery , one year post-surgery | 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 | 30 days and one year post-surgery | The composite number of adverse events reported per group at 30 days and then one year post surgery |
| Day of Ambulation | theatre day, day 1 post-surgery, day two post-surgery | Proportion of patients per day to ambulate for the first time with the physiotherapist \> 3 Metres |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Controlled Epidural (PCEA) A lumbar epidural was sited 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 until the following morning (post-operative day one). 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). | 121 |
| Local Infiltration Analgesia (LIA) 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.
Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. | 121 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Protocol Violation | 12 | 8 |
Baseline characteristics
| Characteristic | Patient Controlled Epidural (PCEA) | Local Infiltration Analgesia (LIA) | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 10 | 68 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 7.6 |
| Body Mass Index | 31 kilogrammes per meter squared STANDARD_DEVIATION 8 | 31 kilogrammes per meter squared STANDARD_DEVIATION 8 | 31 kilogrammes per meter squared STANDARD_DEVIATION 8 |
| Region of Enrollment United Kingdom | 121 participants | 121 participants | 242 participants |
| Sex: Female, Male Female | 66 Participants | 71 Participants | 137 Participants |
| Sex: Female, Male Male | 55 Participants | 50 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 109 | 0 / 113 |
| serious Total, serious adverse events | 2 / 109 | 6 / 113 |
Outcome results
Primary
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
Population: Patients included following randomisation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Proportion of Patients Discharged From Rehabilitation by Day Four | 77 percentage of patients |
| Local Infiltration Analgesia (LIA) | Proportion of Patients Discharged From Rehabilitation by Day Four | 82 percentage of patients |
p-value: 0.332Chi-squared
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Average Post-operative Length of Stay | 4 days |
| Local Infiltration Analgesia (LIA) | Average Post-operative Length of Stay | 4 days |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Controlled Epidural (PCEA) | Day of Ambulation | Theatre Day | 35 percentage of patients |
| Patient Controlled Epidural (PCEA) | Day of Ambulation | Post-operative day one | 65 percentage of patients |
| Patient Controlled Epidural (PCEA) | Day of Ambulation | Post-operative day two | 4 percentage of patients |
| Local Infiltration Analgesia (LIA) | Day of Ambulation | Theatre Day | 51 percentage of patients |
| Local Infiltration Analgesia (LIA) | Day of Ambulation | Post-operative day one | 49 percentage of patients |
| Local Infiltration Analgesia (LIA) | Day of Ambulation | Post-operative day two | 0 percentage of patients |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation | 80 angle of flexion (degree) |
| Local Infiltration Analgesia (LIA) | Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation | 80 angle of flexion (degree) |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patient Controlled Epidural (PCEA) | Patient Reported Outcome Measure - Oxford Knee Score | Pre-operative Oxford Score | 43 units on a scale |
| Patient Controlled Epidural (PCEA) | Patient Reported Outcome Measure - Oxford Knee Score | Six week follow up score | 28 units on a scale |
| Patient Controlled Epidural (PCEA) | Patient Reported Outcome Measure - Oxford Knee Score | One year Follow up score | 19 units on a scale |
| Local Infiltration Analgesia (LIA) | Patient Reported Outcome Measure - Oxford Knee Score | Pre-operative Oxford Score | 43 units on a scale |
| Local Infiltration Analgesia (LIA) | Patient Reported Outcome Measure - Oxford Knee Score | Six week follow up score | 26 units on a scale |
| Local Infiltration Analgesia (LIA) | Patient Reported Outcome Measure - Oxford Knee Score | One year Follow up score | 19 units on a scale |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Post-operative Nausea and Vomiting Scores | 16 percentage of patients reporting PONV |
| Local Infiltration Analgesia (LIA) | Post-operative Nausea and Vomiting Scores | 14 percentage of patients reporting PONV |
Secondary
Post-operative Urinary Catheterisation Rates
% of patients requiring catheterisation for urinary retention post-surgery
Time frame: 72 hours post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Post-operative Urinary Catheterisation Rates | 9.2 percentage of patients catheterised |
| Local Infiltration Analgesia (LIA) | Post-operative Urinary Catheterisation Rates | 4.4 percentage of patients catheterised |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Controlled Epidural (PCEA) | Total Number of Reported Participants With Complications and/or Adverse Events | Reported complications at 30 days | 0 participants |
| Patient Controlled Epidural (PCEA) | Total Number of Reported Participants With Complications and/or Adverse Events | Reported complications at one year | 2 participants |
| Local Infiltration Analgesia (LIA) | Total Number of Reported Participants With Complications and/or Adverse Events | Reported complications at 30 days | 2 participants |
| Local Infiltration Analgesia (LIA) | Total Number of Reported Participants With Complications and/or Adverse Events | Reported complications at one year | 4 participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Controlled Epidural (PCEA) | Verbal Rating Score (VRS) Pain Scores | Theatre Day( asked at 24 hrs) | 3 units on a scale | Standard Deviation 4 |
| Patient Controlled Epidural (PCEA) | Verbal Rating Score (VRS) Pain Scores | Post-operative day one( asked at 48hrs) | 3 units on a scale | Standard Deviation 3 |
| Patient Controlled Epidural (PCEA) | Verbal Rating Score (VRS) Pain Scores | Post-operative day two(asked 72 hrs) | 3 units on a scale | Standard Deviation 2 |
| Local Infiltration Analgesia (LIA) | Verbal Rating Score (VRS) Pain Scores | Theatre Day( asked at 24 hrs) | 3 units on a scale | Standard Deviation 4 |
| Local Infiltration Analgesia (LIA) | Verbal Rating Score (VRS) Pain Scores | Post-operative day one( asked at 48hrs) | 4 units on a scale | Standard Deviation 3 |
| Local Infiltration Analgesia (LIA) | Verbal Rating Score (VRS) Pain Scores | Post-operative day two(asked 72 hrs) | 4 units on a scale | Standard Deviation 3 |