Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty Within an Enhanced Recovery Programme - a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478372
• Other study ID #: 09/ORTH/01
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: October 20, 2015
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2015
• Source: Golden Jubilee National Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: November 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.
• Local Infiltration Analgesia (LIA)
Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital	Glasgow Caledonian University

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	96 hours	No
Secondary	Average Post-operative Length of Stay	Participants will be followed for the duration of hospital stay, an expected average of 5 days	Average number of days spent in hospital follwoing surgery, an expected average of 5 days	No
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	24hours, 48 hours and 72 hours post-surgery	No
Secondary	Post-operative Urinary Catheterisation Rates	% of patients requiring catheterisation for urinary retention post-surgery	72 hours post-surgery	No
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	24hours, 48 hours and 72 hours post-surgery	No
Secondary	Day of Ambulation	Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres	theatre day, day 1 post-surgery, day two post-surgery	No
Secondary	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)	No
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	one week prior to surgery, 6 weeks post-surgery , one year post-surgery	No
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	30 days and one year post-surgery	Yes