MedDataX Logo

Preanalgesic Effect of Gabapentin in Total Knee Repair

NCT ID: NCT00279487

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

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

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Arm 2

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gabapentin

Intervention Type DRUG

Placebos

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Texas Health Resources

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rob Hutchison

Role: PRINCIPAL_INVESTIGATOR

Texas Health Resources

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Presbyterian Hospital of Dallas

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P768

Identifier Type: -

Identifier Source: org_study_id