NCT01429480

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

September 4, 2011

Last Update Submit

September 6, 2011

Conditions

Pain

Keywords

Analgesia, postoperative

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

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

    2 days postoperatively

Study Arms (3)

TAP Block

ACTIVE COMPARATOR
Procedure: Preoperative Ultrasound Guided Posterior TAP Block

II/IH Block

ACTIVE COMPARATOR
Procedure: Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block

Control Group

ACTIVE COMPARATOR
Drug: Patient controlled analgesia

Interventions

Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric BlockPROCEDURE
II/IH Block
Preoperative Ultrasound Guided Posterior TAP BlockPROCEDURE
TAP Block
Patient controlled analgesiaDRUG
Control Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

Related Publications (1)

  • Stav A, Reytman L, Stav MY, Troitsa A, Kirshon M, Alfici R, Dudkiewicz M, Sternberg A. Transversus Abdominis Plane Versus Ilioinguinal and Iliohypogastric Nerve Blocks for Analgesia Following Open Inguinal Herniorrhaphy. Rambam Maimonides Med J. 2016 Jul 28;7(3):e0021. doi: 10.5041/RMMJ.10248.

    PMID: 27487311DERIVED

Related Links

MeSH Terms

Conditions

PainAgnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2011

First Posted

September 7, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

IL(1)