Total Knee Arthroplasty
Conditions
Keywords
Epidural, Local infiltration, Knee, Arthroplasty
Brief summary
Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome. Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.
Detailed description
Study design: Prospective randomised study Study population: Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study. Intervention: The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin. Primary study parameters/outcome of the study: NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest. Secondary study parameters/outcome of the study: Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.
Interventions
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older and legally responsible * Waiting for total knee replacement surgery * Informed consent
Exclusion criteria
* Contraindications for epidural analgesia * Aortic Valve stenosis * Severely compromised cardiac function * infection near epidural punction site * Redo knee surgery * Previous arthrotomies * Allergy/Hypersensitivity for study mediation or all other used medication * Participation in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS score in rest | 3 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speed of mobilisation | 3 days after surgery | — |
| Postoperative morphine consumption | 3 days after surgery | Daily morphine consumption (mg) per day |
| NRS score during flexion exercise | 3 days after surgery | — |
| NRS score during walking exercise | 3 days after surgery | — |
Countries
Netherlands
Outcome results
None listed