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Analgesia After Total Knee Replacement Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01489631
First Posted: December 9, 2011
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leon Timmerman, St. Antonius Hospital
  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: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Leon Timmerman, St. Antonius Hospital:

Primary Outcome Measures:
  • NRS score in rest [ Time Frame: 3 days after surgery ]

Secondary Outcome Measures:
  • 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489631


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

Responsible Party: Leon Timmerman, anesthesiologist, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01489631     History of Changes
Other Study ID Numbers: TKP-37796
First Submitted: December 8, 2011
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