Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Postoperative Pain Clinical Trial

Official title:

Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507363
• Other study ID #: THL-06-11
• Secondary ID: 2011-003105-22H-
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2012
• Last updated: April 10, 2014
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Postoperative Sedation

Intervention

Drug:
• Gabapentin
Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery
• Gabapentin
Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery
• Placebo
Placebo tablets for 7 days, starting on the day of surgery

Locations

Country	Name	City	State
Denmark	Dep. of ortopedic surgery, Aalborg Sygehus	Aalborg
Denmark	Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital	Copenhagen	Hvidovre
Denmark	Dep. of ortopedic surgery, Esbjerg Sygehus	Esbjerg

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)	At 24 hour	No
Secondary	Sedation	Sedation at 6 hours, numeric range scale (NRS, 0-10)	At 6 hours	Yes
Secondary	Pain	Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)	1 week	No
Secondary	Cumulated pain scores	Cumulated pain scores for pain the first week after TKA	1 week	No
Secondary	Amount of rescue analgesic	Amount of rescue analgesic the first week after TKA, mg	1 week	No
Secondary	Side effects	Side effects the first week after TKA	1 week	Yes
Secondary	Cumulated side effects scores	Cumulated side effects scores the first week after TKA	1 week	Yes
Secondary	Amount of ondansetron and sleeping medicine	Amount of ondansetron and sleeping medicine the first week after TKA, mg	1 week	No
Secondary	Anxiety and depression	Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale	1 week	No
Secondary	Gabapentin level in blood-sample	Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration	1 Day	Yes