N/A
N=242
Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02478372 ↗Enrolled (actual)
242
Serious AEs
3.6%
Results posted
Nov 2015
Primary outcome: Primary: Proportion of Patients Discharged From Rehabilitation by Day Four — 77; 82 percentage of patients — p=0.332
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Controlled Epidural (PCEA) (Drug); Local Infiltration Analgesia (LIA) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Golden Jubilee National Hospital
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Discharged From Rehabilitation by Day Four |
77; 82 | 0.332 |
| SECONDARY Average Post-operative Length of Stay |
4; 4 | — |
| SECONDARY Verbal Rating Score (VRS) Pain Scores |
3; 3; 3; 4; 3; 4 | — |
| SECONDARY Post-operative Urinary Catheterisation Rates |
9.2; 4.4 | — |
| SECONDARY Post-operative Nausea and Vomiting Scores |
16; 14 | — |
| SECONDARY Day of Ambulation |
35; 51; 65; 49; 4; 0 | — |
| SECONDARY Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation |
80; 80 | — |
| SECONDARY Patient Reported Outcome Measure - Oxford Knee Score |
43; 43; 28; 26; 19; 19 | — |
| SECONDARY Total Number of Reported Participants With Complications and/or Adverse Events |
0; 2; 2; 4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02478372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.