Comparison of TAP (Transversus Abdominis Plane) and Ilioi... | NCT01429480

Studies
Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy

NCT01429480

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Sep 7, 2011Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block
Preoperative Ultrasound Guided Posterior TAP Block
Patient controlled analgesia

Countries

Israel

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

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Sep 4, 2011

First Submission Date that Met QC Criteria

Sep 6, 2011

First Posted Date

Sep 7, 2011Estimated

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

Sep 6, 2011

Last Update Posted Date

Sep 7, 2011Estimated

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

TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. The researchers wish to investigate whether the TAP block is as effective as the ilioinguinal/iliohypogastric nerve block?

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TAP Block	Active Comparator	Procedure: Preoperative Ultrasound Guided Posterior TAP Block
II/IH Block	Active Comparator	Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block
Control Group	Active Comparator	Drug: Patient controlled analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block	Procedure		II/IH Block
Preoperative Ultrasound Guided Posterior TAP Block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pain	Intensity of pain in rest and during movement at the operation day and 2 days postoperaive.	2 days postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair

Exclusion Criteria:

Inability to consent to the study
BMI more than 40
Skin infection near injection site
Chronic hepatic or renal failure
Peripheral neuropathy
Proven opioid dependency
Coagulopathy
Thrombocytopenia
Dementia
Lack of orientation
Impossibility to understand VAS
Patients suffering from chronic pain

Accepts Healthy Volunteers

Sex

Male

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center	Recruiting	Hadera		38100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27487311	Derived	Stav A, Reytman L, Stav MY, Troitsa A, Kirshon M, Alfici R, Dudkiewicz M, Sternberg A. Transversus Abdominis Plane Versus Ilioinguinal and Iliohypogastric Nerve Blocks for Analgesia Following Open Inguinal Herniorrhaphy. Rambam Maimonides Med J. 2016 Jul 28;7(3):e0021. doi: 10.5041/RMMJ.10248.

ID	Term
D010146	Pain
D000377	Agnosia

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009422	Nervous System Diseases

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia