Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Phase 4

Completed

• Conditions: Postoperative Pain; Postoperative Sedation
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT01507363
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets for 7 days, starting on the day of surgery
Gabapentin "intermediate"	Gabapentin	Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery
Gabapentin "high"	Gabapentin	Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery

Primary Outcome Measures

Name	Time	Method
Pain	At 24 hour	Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)

Secondary Outcome Measures

Name	Time	Method
Amount of ondansetron and sleeping medicine	1 week	Amount of ondansetron and sleeping medicine the first week after TKA, mg
Anxiety and depression	1 week	Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale
Gabapentin level in blood-sample	1 Day	Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration
Sedation	At 6 hours	Sedation at 6 hours, numeric range scale (NRS, 0-10)
Pain	1 week	Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)
Cumulated pain scores	1 week	Cumulated pain scores for pain the first week after TKA
Amount of rescue analgesic	1 week	Amount of rescue analgesic the first week after TKA, mg
Side effects	1 week	Side effects the first week after TKA
Cumulated side effects scores	1 week	Cumulated side effects scores the first week after TKA

Trial Locations

Locations (3)

Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark

Dep. of ortopedic surgery, Aalborg Sygehus; 🇩🇰 Aalborg, Denmark

Dep. of ortopedic surgery, Esbjerg Sygehus; 🇩🇰 Esbjerg, Denmark