Preanalgesic Effect of Gabapentin in Total Knee Repair | NCT00279487

Studies
Preanalgesic Effect of Gabapentin in Total Knee Repair

NCT00279487

Sponsor

Texas Health Resources

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Gabapentin
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Jan 16, 2006

First Submission Date that Met QC Criteria

Jan 16, 2006

First Posted Date

Jan 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug		Arm 1
Placebos

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rob Hutchison	Texas Health Resources	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Presbyterian Hospital of Dallas		Dallas	Texas	75231	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided