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

This study is currently recruiting participants.

Verified September 2011 by Hillel Yaffe Medical Center

Sponsor:

Information provided by (Responsible Party):

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01429480

First received: September 4, 2011

Last updated: September 6, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 4, 2011
Last Updated Date	September 6, 2011
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 6, 2011)	postoperative pain [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: Yes ] Intensity of pain in rest and during movement at the operation day and 2 days postoperaive.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01429480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy
Official Title ^ICMJE	Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Pain
Intervention ^ICMJE	Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block Procedure: Preoperative Ultrasound Guided Posterior TAP Block Drug: Patient controlled analgesia
Study Arm (s)	Active Comparator: TAP Block Intervention: Procedure: Preoperative Ultrasound Guided Posterior TAP Block Active Comparator: II/IH Block Intervention: Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block Active Comparator: Control Group Intervention: Drug: Patient controlled analgesia
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01429480
Other Study ID Numbers ^ICMJE	0065-11-HYMC
Has Data Monitoring Committee	Yes
Responsible Party	Hillel Yaffe Medical Center
Study Sponsor ^ICMJE	Hillel Yaffe Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hillel Yaffe Medical Center
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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