N/A
Completed N=242
Patient Controlled Epidural Analgesia Versus Local Infiltration Analgesia Following Knee Arthroplasty
Source: ClinicalTrials.gov NCT02478372 ↗Enrolled (actual)
242
Serious AEs
3.6%
Results posted
Nov 2015
Primary outcomePrimary: Proportion of Patients Discharged From Rehabilitation by Day Four — 77; 82 percentage of patients — p=0.332
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.
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 | — |
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. Informational only — not medical advice.