Clinical trial NCT01507363: Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)
Official title: Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Sedation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2012-01-10
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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)

Primary outcomes:
measure: Pain
timeFrame: At 24 hour
Secondary outcomes:
measure: Sedation
timeFrame: At 6 hours
measure: Pain
timeFrame: 1 week
measure: Cumulated pain scores
timeFrame: 1 week
measure: Amount of rescue analgesic
timeFrame: 1 week
measure: Side effects
timeFrame: 1 week
measure: Cumulated side effects scores
timeFrame: 1 week
measure: Amount of ondansetron and sleeping medicine
timeFrame: 1 week
measure: Anxiety and depression
timeFrame: 1 week
measure: Gabapentin level in blood-sample
timeFrame: 1 Day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital
state: Hvidovre
city: Aalborg
country: Denmark
facility: Dep. of ortopedic surgery, Aalborg Sygehus
city: Esbjerg
country: Denmark
facility: Dep. of ortopedic surgery, Esbjerg Sygehus
Study officials:
affiliation: Regionshospitalet Holstebro
name: Torben B Hansen B Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, MD
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Jørgen B Dahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vejle Sygehus
name: Per W Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Henrik Husted, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte Hospital
name: Søren Solgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg Sygehus
name: Mogens B Laursen, MD, Phd.
role: PRINCIPAL_INVESTIGATOR
affiliation: Esbjerg Sygehus
name: Lars Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: