NCT01589796

Brief Summary

Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The investigators hypothesize that doing TAP block closer to the middle of the abdomen would result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric nerves.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

April 26, 2012

Last Update Submit

April 30, 2012

Conditions

Abdominal Muscles/UltrasonographyAdultAmbulatory Surgical ProceduresAnesthetics, Local/Administration & DosageRopivacaine/Administration & DosageRopivacaine/Analogs & DerivativesHernia, Inguinal/SurgeryHumansNerve Block/MethodsPain Measurement/MethodsPain, Postoperative/Prevention & ControlUltrasonography, Interventional

Keywords

anesthesiaregional anesthetic techniques: transversus abdominis plane block, ilioinguinal nerve block, iliohypogastric nerve blocksurgery, inguinal herniorrhaphypain, postoperativesurgery, inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption after two above mentioned techniques

    48 hours

Study Arms (2)

classic TAP

ACTIVE COMPARATOR

classic US-guided TAP block in a space between iliac crest and the costal margin in the region of the anterior axillary line

Procedure: TAP block

Medial TAP

ACTIVE COMPARATOR

US-guided TAP block in a space between iliac crest and the costal margin within 1 inch lateral to transversus abdominis muscle origination

Procedure: TAP block

Interventions

TAP blockPROCEDURE

injection of 20ml of Ropivacaine 0.5% in the proper place once it is identified

Medial TAPclassic TAP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age 18 - 75 years of age undergoing open inguinal hernia repair.
  • Ability to read and write English

You may not qualify if:

  • Patients undergoing other concomitant procedure
  • Patients with history of diabetes or chronic steroid use
  • Patients with chronic or recent (within 1 week prior to procedure) opioid use.
  • Patients without the mental capacity to consent for the procedure/study.
  • Patients requiring a translator in order to sign the consent for the procedure/study.
  • Patients with a history of allergic reactions to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tully Health Center

Stamford, Connecticut, 06902, United States

RECRUITING

Stamford Hospital

Stamford, Connecticut, 06904, United States

RECRUITING

Related Publications (5)

  • Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.

    PMID: 21177284BACKGROUND

  • Fredrickson MJ, Paine C, Hamill J. Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Paediatr Anaesth. 2010 Nov;20(11):1022-7. doi: 10.1111/j.1460-9592.2010.03432.x.

    PMID: 20964768BACKGROUND

  • Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

    PMID: 18020088BACKGROUND

  • Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.

    PMID: 22012289BACKGROUND

  • Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x.

    PMID: 15025612BACKGROUND

MeSH Terms

Conditions

HerniaPainPain, Postoperative

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Vlad Frenk, MD

CONTACT

203 276-7490vfrenk@stmahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending anesthesiologist

Study Record Dates

First Submitted

April 26, 2012

First Posted

May 2, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2013

Last Updated

May 2, 2012

Record last verified: 2012-04

Locations

US(2)