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Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Primary Purpose

Postoperative Pain, Postoperative Sedation

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Gabapentin

Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital
Dep. of ortopedic surgery, Aalborg Sygehus
Dep. of ortopedic surgery, Esbjerg Sygehus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin "high"

Gabapentin "intermediate"

Placebo

Arm Description

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

Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery

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

Outcomes

Primary Outcome Measures

Pain

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

Secondary Outcome Measures

Sedation

Sedation at 6 hours, numeric range scale (NRS, 0-10)

Pain

Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)

Cumulated pain scores

Cumulated pain scores for pain the first week after TKA

Amount of rescue analgesic

Amount of rescue analgesic the first week after TKA, mg

Side effects

Side effects the first week after TKA

Cumulated side effects scores

Cumulated side effects scores the first week after TKA

Amount of ondansetron and sleeping medicine

Amount of ondansetron and sleeping medicine the first week after TKA, mg

Anxiety and depression

Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale

Gabapentin level in blood-sample

Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration

Full Information

NCT ID

NCT01507363

First Posted

January 6, 2012

Last Updated

April 10, 2014

Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01507363

Brief Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Postoperative Sedation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gabapentin "high"

Arm Type

Active Comparator

Arm Description

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

Arm Title

Gabapentin "intermediate"

Arm Type

Active Comparator

Arm Description

Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Description

Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain

Description

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

Time Frame

At 24 hour

Secondary Outcome Measure Information:

Title

Sedation

Description

Sedation at 6 hours, numeric range scale (NRS, 0-10)

Time Frame

At 6 hours

Title

Pain

Description

Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)

Time Frame

1 week

Title

Cumulated pain scores

Description

Cumulated pain scores for pain the first week after TKA

Time Frame

1 week

Title

Amount of rescue analgesic

Description

Amount of rescue analgesic the first week after TKA, mg

Time Frame

1 week

Title

Side effects

Description

Side effects the first week after TKA

Time Frame

1 week

Title

Cumulated side effects scores

Description

Cumulated side effects scores the first week after TKA

Time Frame

1 week

Title

Amount of ondansetron and sleeping medicine

Description

Amount of ondansetron and sleeping medicine the first week after TKA, mg

Time Frame

1 week

Title

Anxiety and depression

Description

Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale

Time Frame

1 week

Title

Gabapentin level in blood-sample

Description

Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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)

Overall Study Officials: