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Analgesia After Total Knee Replacement Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
| Total Knee Arthroplasty | Drug: naropin Drug: marcaine Drug: sufentanil Drug: neurontin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery |
- NRS score in rest [ Time Frame: 3 days after surgery ]
- Speed of mobilisation [ Time Frame: 3 days after surgery ]
- Postoperative morphine consumption [ Time Frame: 3 days after surgery ]Daily morphine consumption (mg) per day
- NRS score during flexion exercise [ Time Frame: 3 days after surgery ]
- NRS score during walking exercise [ Time Frame: 3 days after surgery ]
| Enrollment: | 81 |
| Study Start Date: | March 2013 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: epidural analgesia
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.
|
Drug: marcaine
bupivacaine 0,125%
Other Name: bupivacaine
Drug: sufentanil
sufentanil 1mcg/ml
Other Name: sufenta forte
|
|
Active Comparator: local infiltration
The second group will receive local infiltration with ropivacaine of the knee during surgery.
|
Drug: naropin
ropivacaine 0,2%, 3x 50 ml during surgery
Other Name: ropivacaine
|
|
Active Comparator: local infiltration and gabapentin
The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.
|
Drug: naropin
ropivacaine 0,2%, 3x 50 ml during surgery
Other Name: ropivacaine
Drug: neurontin
gabapentin 600 mg pre-operative 3 dd 300 mg
Other Name: gabapentin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01489631
| Netherlands | |
| St. Antonius Hospital | |
| Nieuwegein, Netherlands, 3430 EM | |
| Principal Investigator: | Leon Timmerman, MD | Anesthesiologist |
| Principal Investigator: | Louis N Marting, MD | Orthopedic surgeon |
More Information
| Responsible Party: | Leon Timmerman, anesthesiologist, St. Antonius Hospital |
| ClinicalTrials.gov Identifier: | NCT01489631 History of Changes |
| Other Study ID Numbers: |
TKP-37796 |
| Study First Received: | December 8, 2011 |
| Last Updated: | June 4, 2015 |
Keywords provided by Leon Timmerman, St. Antonius Hospital:
|
Epidural Local infiltration Knee Arthroplasty |
Additional relevant MeSH terms:
|
Bupivacaine Ropivacaine Sufentanil Gabapentin gamma-Aminobutyric Acid Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents GABA Agents Analgesics, Opioid Narcotics Adjuvants, Anesthesia Anesthetics, Intravenous |
ClinicalTrials.gov processed this record on July 27, 2017