OsteoarthritisNCT02478372
Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty
A study testing Local Infiltration Analgesia (LIA) in people with Osteoarthritis, run by Golden Jubilee National Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Local Infiltration Analgesia (LIA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients (age> 18years old) undergoing primary unilateral total knee arthroplasty (TKA) with a clinical diagnosis of osteoarthritis
Who cannot join
- 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
About this study
Official title: Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty Within an Enhanced Recovery Programme - a Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Patient Controlled Epidural (PCEA), Local Infiltration Analgesia (LIA)
- Keywords
- local infiltration analgesia, Epidural, Enhanced Recovery, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Controlled Epidural (PCEA)Drug
Also called Levobupivacaine and Bupivacaine
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.
Local Infiltration Analgesia (LIA)Drug
Also called Ropivacaine
Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Active comparator | 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). Receives: Drug: Patient Controlled Epidural (PCEA) |
| Local Infiltration Analgesia (LIA) | Experimental | 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. Receives: Drug: Local Infiltration Analgesia (LIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 96 hours
Secondary outcomes (8)
Average Post-operative Length of Stay
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured: 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
Measured: 24hours, 48 hours and 72 hours post-surgery
Post-operative Urinary Catheterisation Rates
% of patients requiring catheterisation for urinary retention post-surgery
Measured: 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
Measured: 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
Measured: theatre day, day 1 post-surgery, day two post-surgery
Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation
Measured: 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
Measured: 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
Measured: 30 days and one year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- Glasgow Caledonian University
- Responsible party
- Sponsor
- Investigators
- David A McDonald, BSc, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478372
- Sponsor's protocol ID
- 09/ORTH/01
- Status last verified
- Oct 2015
- First submitted
- 2 Apr 2015
- Last updated
- 10 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty Within an Enhanced Recovery Programme - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02478372
- Acronym / sponsor ID
- 09/ORTH/01
- Conditions
- Osteoarthritis
- Keywords
- local infiltration analgesia, Epidural, Enhanced Recovery, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- Glasgow Caledonian University
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Posted 10 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Controlled Epidural (PCEA) | Active comparator | Drug: 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). |
| Local Infiltration Analgesia (LIA) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients (age> 18years old) undergoing primary unilateral total knee arthroplasty (TKA) with a clinical diagnosis of osteoarthritis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Controlled Epidural (PCEA)Also: Levobupivacaine and BupivacaineFollowing 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. | Drug | Patient Controlled Epidural (PCEA) |
| Local Infiltration Analgesia (LIA)Also: RopivacaineSubcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. | Drug | Local Infiltration Analgesia (LIA) |
Primary outcome
Proportion of Patients Discharged From Rehabilitation by Day Four
Time frame: 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.
8 secondary outcomes
Average Post-operative Length of Stay
Time frame: Average number of days spent in hospital follwoing surgery, an expected average of 5 days
Verbal Rating Score (VRS) Pain Scores
Time frame: 24hours, 48 hours and 72 hours post-surgery
Post-operative Urinary Catheterisation Rates
Time frame: 72 hours post-surgery
Post-operative Nausea and Vomiting Scores
Time frame: 24hours, 48 hours and 72 hours post-surgery
Day of Ambulation
Time frame: theatre day, day 1 post-surgery, day two post-surgery
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
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
Time frame: 30 days and one year post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A McDonald, BSc principal investigator
Golden Jubilee National Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Local Infiltration Analgesia (LIA) in people with Osteoarthritis, run by Golden Jubilee National Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Discharged From Rehabilitation by Day Four (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.