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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epidural analgesia | Active Comparator | 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 | Active Comparator | The second group will receive local infiltration with ropivacaine of the knee during surgery. |
|
| local infiltration and gabapentin | Active Comparator | The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naropin | Drug | ropivacaine 0,2%, 3x 50 ml during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS score in rest | 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of mobilisation | 3 days after surgery | |
| Postoperative morphine consumption | Daily morphine consumption (mg) per day | 3 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Timmerman, MD | Anesthesiologist | Principal Investigator |
| Louis N Marting, MD | Orthopedic surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital | Nieuwegein | 3430 EM | Netherlands |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| D017409 | Sufentanil |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| marcaine | Drug | bupivacaine 0,125% |
|
|
| sufentanil | Drug | sufentanil 1mcg/ml |
|
|
| neurontin | Drug | gabapentin 600 mg pre-operative 3 dd 300 mg |
|
|
| NRS score during flexion exercise | 3 days after surgery |
| NRS score during walking exercise | 3 days after surgery |
| D000588 |
| Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |