Transversus Abdominis Plane Block and Inguinal Hernia Repair

NCT ID: NCT02030223

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.

Detailed Description

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Conditions

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Inguinal Hernia Abdominal Wall Muscles Regional Anesthesia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transversus abdominis plane block with 20 ml ropivacaine 0,75%

Transversus abdominis plane block with 20 ml ropivacaine 0,75%

Group Type ACTIVE_COMPARATOR

Transversus abdominis plane block

Intervention Type PROCEDURE

ultrasound guided transversus abdominis plane block

Transversus abdominis plane block with 20 ml saline

Transversus abdominis plane block with 20 ml saline

Group Type PLACEBO_COMPARATOR

Transversus abdominis plane block

Intervention Type PROCEDURE

ultrasound guided transversus abdominis plane block

Interventions

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Transversus abdominis plane block

ultrasound guided transversus abdominis plane block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

ASA I-III patients undergoing inguinal hernia repair with a mesh

age between 18 and 75 years old

ability to read and write greek

\-

Exclusion Criteria

* Inability to consent to the study
* BMI \>40kg/m2
* Skin infection at the puncture site
* Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
* Preoperative use of opioids or NSAID's for chronic pain conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papacharalampous Panagiota

OTHER

Sponsor Role lead

Responsible Party

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Papacharalampous Panagiota

Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Erifyli Argyra, MD, PhD

Role: STUDY_CHAIR

Aretaieion University Hospital

Kassiani Theodoraki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aretaieion University Hospital

Locations

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Aretaieion University Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.

Reference Type RESULT
PMID: 23160979 (View on PubMed)

Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.

Reference Type RESULT
PMID: 23549122 (View on PubMed)

Related Links

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http://WWW.NYSORA.COM

THE JOURNAL OF THE NEW YORK SCHOOL OF REGIONAL ANESTHESIA

Other Identifiers

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PAM-2345-1786

Identifier Type: -

Identifier Source: org_study_id

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