NCT01507363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2012

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

January 6, 2012

Last Update Submit

April 10, 2014

Conditions

Postoperative PainPostoperative Sedation

Outcome Measures

Primary Outcomes (1)

  • Pain

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

    At 24 hour

Secondary Outcomes (9)

  • Sedation

    At 6 hours

  • Pain

    1 week

  • Cumulated pain scores

    1 week

  • Amount of rescue analgesic

    1 week

  • Side effects

    1 week

  • +4 more secondary outcomes

Study Arms (3)

Gabapentin "high"

ACTIVE COMPARATOR

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

Drug: Gabapentin

Gabapentin "intermediate"

ACTIVE COMPARATOR

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

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GabapentinDRUG

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

Gabapentin "high"
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary, unilateral total knee arthroplasty (TKA)
  • Age 50-85 years
  • Ethnic Danes

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dep. of ortopedic surgery, Aalborg Sygehus

Aalborg, Aalborg, 9000, Denmark

Location

Dep. of ortopedic surgery, Esbjerg Sygehus

Esbjerg, Esbjerg, 6700, Denmark

Location

Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Torben B Hansen B Hansen, MD

    Regionshospitalet Holstebro

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD

    Rigshospitalet, Denmark

    STUDY DIRECTOR

  • Jørgen B Dahl, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Per W Kristensen, MD

    Vejle Sygehus

    PRINCIPAL INVESTIGATOR

  • Henrik Husted, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

  • Søren Solgaard, MD

    Gentofte Hospital

    PRINCIPAL INVESTIGATOR

  • Mogens B Laursen, MD, Phd.

    Aalborg Sygehus

    PRINCIPAL INVESTIGATOR

  • Lars Hansen, MD

    Esbjerg Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, principal and koordinating investigator

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 10, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

DK(3)