Postoperative Pain Clinical Trial
Official title:
Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study
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.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Lundbeck Foundation |
Denmark,
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 |
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