Total Knee Arthroplasty Clinical Trial
Official title:
Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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