NCT00279487

Brief Summary

The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable pain

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 16, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

First QC Date

January 16, 2006

Last Update Submit

October 24, 2016

Conditions

Pain

Keywords

Patients undergoing total knee replacement who received pain management by the following modality:IV PCA opioidLocal femoral nerve block with 1.5% Mepivacaine & 0.5% Ropivacaine

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Patients will receive 1200mg gabapentin 1-2 hours prior to surgery.

Drug: Gabapentin

Arm 2

PLACEBO COMPARATOR

Patients will receive placebo 1-2 hours prior to surgery.

Drug: Placebos

Interventions

GabapentinDRUG
Arm 1
PlacebosDRUG
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing total knee replacement who received pain management by the following modality:
  • Intravenous patient-controlled analgesia (IV-PCA) opioid
  • Local femoral nerve block with 1.5% mepivacaine 20 ml and 0.5% ropivacaine 20 ml

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rob Hutchison

    Texas Health Resources

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 19, 2006

Study Completion

August 1, 2007

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)