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

September 4, 2011
September 6, 2011
August 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01429480 on ClinicalTrials.gov Archive Site
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Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy
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?

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Pain
  • Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block
  • Procedure: Preoperative Ultrasound Guided Posterior TAP Block
  • Drug: Patient controlled analgesia
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Not Provided
Israel
 
NCT01429480
0065-11-HYMC
Yes
Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
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Not Provided
Hillel Yaffe Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP