Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty

NCT02478372 | Completed Results

• 1 other identifier: 09/ORTH/01
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

local infiltration analgesia; Epidural; Enhanced Recovery; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Average Post-operative Length of Stay

  Average number of days spent in hospital follwoing surgery, an expected average of 5 days

• Verbal Rating Score (VRS) Pain Scores

  24hours, 48 hours and 72 hours post-surgery

• Post-operative Urinary Catheterisation Rates

  72 hours post-surgery

• Post-operative Nausea and Vomiting Scores

  24hours, 48 hours and 72 hours post-surgery

• Day of Ambulation

  theatre day, day 1 post-surgery, day two post-surgery

Study Arms (2)

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).

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.

Drug: Local Infiltration Analgesia (LIA)

Interventions

Patient Controlled Epidural (PCEA) DRUG

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.

Also known as: Levobupivacaine and Bupivacaine

Patient Controlled Epidural (PCEA)

Local Infiltration Analgesia (LIA) DRUG

Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.

Also known as: Ropivacaine

Local Infiltration Analgesia (LIA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients (age\> 18years old) undergoing primary unilateral total knee arthroplasty (TKA) with a clinical diagnosis of osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead
• Glasgow Caledonian University: collaborator

MeSH Terms

Conditions

Osteoarthritis

Interventions

Levobupivacaine; Bupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: David McDonald
• Organization: Golden Jubilee National Hospital

david.mcdonald@nhs.net

07914861078

Study Officials

• David A McDonald, BSc

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: June 23, 2015
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2012
• Last Updated: November 10, 2015
• Results First Posted: November 10, 2015

Record last verified: 2015-10