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Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

This study is currently recruiting participants.
Verified June 2013 by Hvidovre University Hospital
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01507363
First received: January 6, 2012
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  Purpose

Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.


Condition Intervention Phase
Postoperative Pain
Postoperative Sedation
 Drug: Gabapentin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: At 24 hour ] [ Designated as safety issue: No ]
    Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)


Secondary Outcome Measures:
  • Sedation [ Time Frame: At 6 hours ] [ Designated as safety issue: Yes ]
    Sedation at 6 hours, numeric range scale (NRS, 0-10)

  • Pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)

  • Cumulated pain scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Cumulated pain scores for pain the first week after TKA

  • Amount of rescue analgesic [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Amount of rescue analgesic the first week after TKA, mg

  • Side effects [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Side effects the first week after TKA

  • Cumulated side effects scores [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Cumulated side effects scores the first week after TKA

  • Amount of ondansetron and sleeping medicine [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Amount of ondansetron and sleeping medicine the first week after TKA, mg

  • Anxiety and depression [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale

  • Gabapentin level in blood-sample [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
    Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin "high"
Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery
 Drug: Gabapentin
Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery
Active Comparator: Gabapentin "intermediate"
Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery
 Drug: Gabapentin
Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery
Placebo Comparator: Placebo
Placebo tablets for 7 days, starting on the day of surgery
 Drug: Placebo
Placebo tablets for 7 days, starting on the day of surgery

Detailed Description:

Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary, unilateral total knee arthroplasty (TKA)
  • Age 50-85 years
  • Ethnic Danes

Exclusion Criteria:

  • Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)
  • History of depression or mania
  • History of alcohol or drug abuse
  • History of malignancy
  • History of epilepsia
  • BMI > 40
  • Disease affecting central or peripheral nerve function
  • History of dementia
  • History of renal insufficiency
  • Allergy to Gabapentin
  • Women with menstruation (last 2 years)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507363

Contacts
Contact: Troels H Lunn, MD +4526250006 lunn@dadlnet.dk

Locations
Denmark
Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital Recruiting
Copenhagen, Hvidovre, Denmark
Contact: Troels H Lunn, MD     +4526250006     lunn@dadlnet.dk    
Principal Investigator: Troels H Lunn, MD            
Dep. of ortopedic surgery, Aalborg Sygehus Recruiting
Aalborg, Denmark, 9000
Contact: Mogens B Laursen, MD, Phd.     +45 99 32 51 58        
Principal Investigator: Mogens B Laursen, MD, Phd            
Dep. of ortopedic surgery, Esbjerg Sygehus Recruiting
Esbjerg, Denmark, 6700
Contact: Lars Hansen, MD     +45 79 18 20 00        
Principal Investigator: Lars Hansen, MD            
Dep. of ortopedic surgery, Gentofte Hospital Not yet recruiting
Hellerup, Denmark, 2900
Contact: Søren Solgaard, MD     +45 39 77 39 77        
Principal Investigator: Søren Solgaard, MD            
Dep. of ortopedic surgery, Regionshospitalet Holstebro Not yet recruiting
Holstebro, Denmark, 7500
Contact: Torben B Hansen, MD     +45 99 12 50 00        
Principal Investigator: Torben B Hansen, MD            
Dep. of ortopedic surgery, Vejle Sygehus Not yet recruiting
Vejle, Denmark, 7100
Contact: Per W Kristensen, MD     +45 79 40 50 00        
Principal Investigator: Per W Kristensen, MD            
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
Investigators
Principal Investigator: Torben B Hansen B Hansen, MD Regionshospitalet Holstebro
Study Director: Henrik Kehlet, MD Rigshospitalet, Denmark
Principal Investigator: Jørgen B Dahl, MD Rigshospitalet, Denmark
Principal Investigator: Per W Kristensen, MD Vejle Sygehus
Principal Investigator: Henrik Husted, MD Hvidovre Hospital
Principal Investigator: Søren Solgaard, MD Gentofte Hospital
Principal Investigator: Mogens B Laursen, MD, Phd. Aalborg Sygehus
Principal Investigator: Lars Hansen, MD Esbjerg Sygehus
  More Information

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, principal and koordinating investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01507363     History of Changes
Other Study ID Numbers: THL-06-11, 2011-003105-22, H-4-2011-082
Study First Received: January 6, 2012
Last Updated: June 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Gabapentin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on June 17, 2013