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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
  Purpose

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?


Condition Intervention
Pain
 Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block
Procedure: Preoperative Ultrasound Guided Posterior TAP Block
Drug: Patient controlled analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAP Block Procedure: Preoperative Ultrasound Guided Posterior TAP Block
Active Comparator: II/IH Block Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block
Active Comparator: Control Group Drug: Patient controlled analgesia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429480

Locations
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Anatoly Stav, MD     972-4-630-4529        
Principal Investigator: Anatoly Stav, MD            
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01429480     History of Changes
Other Study ID Numbers: 0065-11-HYMC
Study First Received: September 4, 2011
Last Updated: September 6, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Analgesia, postoperative

ClinicalTrials.gov processed this record on June 17, 2013