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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hillel Yaffe Medical Center.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 29, 2014