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Preanalgesic Effect of Gabapentin in Total Knee Repair

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ClinicalTrials.gov Identifier: NCT00279487
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pain Drug: Gabapentin Drug: Placebos

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preanalgesic Effect of Gabapentin in Total Knee Repair
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm 1
Patients will receive 1200mg gabapentin 1-2 hours prior to surgery.
Drug: Gabapentin
Placebo Comparator: Arm 2
Patients will receive placebo 1-2 hours prior to surgery.
Drug: Placebos


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 years old
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279487


Locations
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Texas Health Resources
Investigators
Principal Investigator: Rob Hutchison Texas Health Resources
More Information

Responsible Party: Texas Health Resources
ClinicalTrials.gov Identifier: NCT00279487     History of Changes
Other Study ID Numbers: P768
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Texas Health Resources:
Patients undergoing total knee replacement who received pain management by the following modality:
IV PCA opioid
Local femoral nerve block with 1.5% Mepivacaine & 0.5% Ropivacaine

Additional relevant MeSH terms:
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents