Text Size

Analgesia After Total Knee Replacement Surgery

This study is not yet open for participant recruitment.
Verified December 2011 by St. Antonius Hospital
Sponsor:
Information provided by (Responsible Party):
Leon Timmerman, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01489631
First received: December 8, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Speed of mobilisation [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
  • postoperative opiate consumption. [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NRS-score [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
  • NRS score in rest, during flexion of the knee and during walking, length of stay. [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (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:

Speed of mobilisation and postoperative opiate consumption.

Secondary 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), quality of analgesia in rest, during flexion of the knee and during walking, length of stay.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489631

Contacts
Contact: Leon Timmerman, Drs +31(0)30-609 ext 2304 l.timmerman@antoniusziekenhuis.nl

Locations
Netherlands
St. Antonius Hospital Not yet recruiting
Nieuwegein, Netherlands, 3430 EM
Principal Investigator: Leon Timmerman, Drs            
Principal Investigator: Louis Marting, Drs            
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Leon Timmerman, MD Anesthesiologist
Principal Investigator: Louis N Marting, MD Orthopedic surgeon
  More Information

No publications provided

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: December 12, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:
Epidural
Local infiltration
Knee
Arthroplasty

Additional relevant MeSH terms:
Bupivacaine
Ropivacaine
Sufentanil
Gabapentin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Analgesics, Opioid
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on May 23, 2013