Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01507363

Enrollment

300

Registered

2012-01-10

Start date

2012-01-31

Completion date

2013-11-30

Last updated

2014-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Postoperative Sedation

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.

Interventions

DRUGGabapentin

Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery

DRUGPlacebo

Placebo tablets for 7 days, starting on the day of surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Sedation	At 6 hours	Sedation at 6 hours, numeric range scale (NRS, 0-10)
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
Cumulated side effects scores	1 week	Cumulated side effects scores the first week after TKA

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026