Analgesia After Total Knee Replacement Surgery
- Conditions
- Total Knee Arthroplasty
- Interventions
- Registration Number
- NCT01489631
- Lead Sponsor
- St. Antonius Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 18 years or older and legally responsible
- Waiting for total knee replacement surgery
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description epidural analgesia marcaine 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. local infiltration naropin The second group will receive local infiltration with ropivacaine of the knee during surgery. epidural analgesia sufentanil 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. local infiltration and gabapentin naropin The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin. local infiltration and gabapentin neurontin The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.
- Primary Outcome Measures
Name Time Method NRS score in rest 3 days after surgery
- Secondary Outcome Measures
Name Time Method NRS score during walking exercise 3 days after surgery Postoperative morphine consumption 3 days after surgery Daily morphine consumption (mg) per day
Speed of mobilisation 3 days after surgery NRS score during flexion exercise 3 days after surgery
Trial Locations
- Locations (1)
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands