Post-Operative Pain Scores and Analgesic Requirements Aft... | NCT00735124

Studies
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy

NCT00735124

Sponsor

University of Oklahoma

Status

Terminated

Last Update Posted

Apr 28, 2017Actual

Enrollment

5Actual

Phase

Phase 2Phase 3

Conditions

Pain
Analgesia
Hernia, Inguinal

Interventions

Gabapentin
placebo

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Changes to surgical practices led to the loss of eligible patients

Expanded Access Info

Start Date

Nov 6, 2008Actual

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 13, 2008

First Submission Date that Met QC Criteria

Aug 13, 2008

First Posted Date

Aug 14, 2008Estimated

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

Apr 26, 2017

Last Update Posted Date

Apr 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

Detailed Description

The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single pre-op dose of Gabapentine	Active Comparator	Active treatment with the study drug	Drug: Gabapentin
Placebo	Placebo Comparator	Placebo arm for blinding the medication	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	1200 mg single dose gabapentin	Single pre-op dose of Gabapentine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy	Post operative pain is reduced when single pre-operative oral dose of	1yrs

Secondary Outcomes

Measure	Description	Time Frame
The post operative analgesia requirement is also reduced	The post operative analgesia requirement is also reduced	1yrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects having elective surgery with open unilateral Inguinal herniorraphy

Exclusion Criteria:

Non elective surgery
Patients currently on gabapentin therapy
Patient hypersensitive to gabapentin surgery
History of alcohol or drug abuse
Patients who are pregnant or who are nursing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Badie Mansour, MD	OUHSC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OUHSC		Oklahoma City	Oklahoma	73152	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
D000377	Agnosia
D006552	Hernia, Inguinal
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

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