Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty

• Sponsor: Golden Jubilee National Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02478372
• Collaborator: Glasgow Caledonian University (Other)
• Enrollment: 242
• Arms: 2
• Duration (Months): 31

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Patient Controlled Epidural (PCEA); Drug: Local Infiltration Analgesia (LIA)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty Within an Enhanced Recovery Programme - a Randomised Controlled Trial
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patient Controlled Epidural (PCEA) 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).	Drug: Patient 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.; Other Names: Levobupivacaine and Bupivacaine
Experimental: 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.	Drug: Local Infiltration Analgesia (LIA); Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.; Other Names: Ropivacaine

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. Post-operative Urinary Catheterisation Rates [72 hours post-surgery]

   % of patients requiring catheterisation for urinary retention post-surgery

4. 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

5. 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

6. 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)]

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Golden Jubilee National Hospital
• Glasgow Caledonian University

Investigators

• Principal Investigator: David A McDonald, BSc, Golden Jubilee National Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Golden Jubilee National Hospital
• ClinicalTrials.gov Identifier: NCT02478372
• Other Study ID Numbers: 09/ORTH/01
• First Posted: Jun 23, 2015
• Last Update Posted: Nov 10, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Golden Jubilee National Hospital: local infiltration analgesia; Epidural; Enhanced Recovery; Total Knee Arthroplasty
• Additional relevant MeSH terms: Osteoarthritis; Bupivacaine; Ropivacaine; Levobupivacaine

Study Results

Participant Flow

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Period Title: Overall Study
STARTED	121	121
Recieved Allocation Intervention	109	113
Reviewed at Six Weeks	108	113
Reviewed at One Year	108	107
COMPLETED	108	107
NOT COMPLETED	13	14

Baseline Characteristics

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)	Total
Arm/Group Description	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).	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.	Total of all reporting groups
Overall Participants	121	121	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (10)	68 (11)	67 (7.6)
Sex: Female, Male (Count of Participants)
Female	66 54.5%	71 58.7%	137 56.6%
Male	55 45.5%	50 41.3%	105 43.4%
Region of Enrollment (participants) [Number]
United Kingdom	121 100%	121 100%	242 100%
Body Mass Index (kilogrammes per meter squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogrammes per meter squared]	31 (8)	31 (8)	31 (8)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients included following randomisation

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Number [percentage of patients]	77	82

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Controlled Epidural (PCEA), Local Infiltration Analgesia (LIA)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.332
	Comments	Significance was set at <0.01
	Method	Chi-squared
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Median (Inter-Quartile Range) [days]	4	4

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Theatre Day( asked at 24 hrs)	3 (4)	3 (4)
Post-operative day one( asked at 48hrs)	3 (3)	4 (3)
Post-operative day two(asked 72 hrs)	3 (2)	4 (3)

4. Secondary Outcome

Title	Post-operative Urinary Catheterisation Rates
Description	% of patients requiring catheterisation for urinary retention post-surgery
Time Frame	72 hours post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Number [percentage of patients catheterised]	9.2	4.4

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Number [percentage of patients reporting PONV]	16	14

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Theatre Day	35	51
Post-operative day one	65	49
Post-operative day two	4	0

7. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Median (Inter-Quartile Range) [angle of flexion (degree)]	80	80

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Pre-operative Oxford Score	43	43
Six week follow up score	28	26
One year Follow up score	19	19

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Controlled Epidural (PCEA)	Local Infiltration Analgesia (LIA)
Arm/Group Description	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).	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.
Measure Participants	109	113
Reported complications at 30 days	0 0%	2 1.7%
Reported complications at one year	2 1.7%	4 3.3%

Adverse Events

Time Frame	30 days post-surgery and one year following surgery
Arm/Group Title	Patient Controlled Epidural (PCEA)		Local Infiltration Analgesia (LIA)
Arm/Group Description	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).		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.
All Cause Mortality
	Patient Controlled Epidural (PCEA)		Local Infiltration Analgesia (LIA)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Patient Controlled Epidural (PCEA)		Local Infiltration Analgesia (LIA)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/109 (1.8%)		6/113 (5.3%)
Cardiac disorders
Acute Myocardial Infarction at one year	1/109 (0.9%)	1	0/113 (0%)	0
Gastrointestinal disorders
GI Bleed at 30 days	0/109 (0%)	0	1/113 (0.9%)	1
General disorders
Death at one year	0/109 (0%)	0	2/113 (1.8%)	2
Renal and urinary disorders
Renal Failure at one year	0/109 (0%)	0	1/113 (0.9%)	1
Skin and subcutaneous tissue disorders
wound Infection at 30 days	0/109 (0%)	0	1/113 (0.9%)	1
Wound Infection at one year	1/109 (0.9%)	1	1/113 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Patient Controlled Epidural (PCEA)		Local Infiltration Analgesia (LIA)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/109 (0%)		0/113 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.