Analgesia After Total Knee Replacement Surgery

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Total Knee Arthroplasty	Drug: naropin; Drug: marcaine; Drug: sufentanil; Drug: neurontin	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	81 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
Study Start Date :	March 2013
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	April 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. NRS score in rest [ Time Frame: 3 days after surgery ]

Secondary Outcome Measures :

1. Speed of mobilisation [ Time Frame: 3 days after surgery ]
2. Postoperative morphine consumption [ Time Frame: 3 days after surgery ]
   Daily morphine consumption (mg) per day
3. NRS score during flexion exercise [ Time Frame: 3 days after surgery ]
4. NRS score during walking exercise [ Time Frame: 3 days after surgery ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3430 EM

Sponsors and Collaborators

St. Antonius Hospital

Investigators

Principal Investigator:	Leon Timmerman, MD	Anesthesiologist
Principal Investigator:	Louis N Marting, MD	Orthopedic surgeon

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Leon Timmerman, anesthesiologist, St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT01489631 History of Changes
Other Study ID Numbers:	TKP-37796
First Posted:	December 9, 2011
Last Update Posted:	June 8, 2015
Last Verified:	June 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