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

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01429480
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block; Procedure: Preoperative Ultrasound Guided Posterior TAP Block; Drug: Patient controlled analgesia	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Aug 1, 2011
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. postoperative pain [2 days postoperatively]

   Intensity of pain in rest and during movement at the operation day and 2 days postoperaive.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

• Hillel Yaffe Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Hillel Yaffe Medical Center
• ClinicalTrials.gov Identifier: NCT01429480
• Other Study ID Numbers: 0065-11-HYMC
• First Posted: Sep 7, 2011
• Last Update Posted: Sep 7, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Hillel Yaffe Medical Center: Analgesia, postoperative

Study Results

No Results Posted as of Sep 7, 2011