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

September 6, 2011 updated by: Hillel Yaffe Medical Center

Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center
        • Principal Investigator:
          • Anatoly Stav, MD
        • Contact:
          • Anatoly Stav, MD
          • Phone Number: 972-4-630-4529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Drug: Patient controlled analgesia
Active Comparator: TAP Block
Procedure: Preoperative Ultrasound Guided Posterior TAP Block
Active Comparator: II/IH Block
Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

September 4, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0065-11-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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