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Transversus Abdominis Plane Block and Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia, Abdominal Wall Muscles, Regional Anesthesia

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Transversus abdominis plane block

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring transversus abdominis plane block, inguinal hernia repair, acute postoperative pain, neuropathic pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aretaieion University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

Transversus abdominis plane block with 20 ml saline

Arm Description

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

Transversus abdominis plane block with 20 ml saline

Outcomes

Primary Outcome Measures

Pain scores at rest and with movement using the numerical rating scale (NRS)

Secondary Outcome Measures

Incidence of chronic pain

Full Information

NCT ID

NCT02030223

First Posted

January 7, 2014

Last Updated

February 16, 2018

Sponsor

Papacharalampous Panagiota

1. Study Identification

Unique Protocol Identification Number

NCT02030223

Brief Title

Transversus Abdominis Plane Block and Inguinal Hernia Repair

Official Title

The Analgesic Efficacy of the Ultrasound Guided Transversus Abdominis Plane Block After Inguinal Hernia Repair With a Mesh.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Papacharalampous Panagiota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia, Abdominal Wall Muscles, Regional Anesthesia, Postoperative Pain

Keywords

transversus abdominis plane block, inguinal hernia repair, acute postoperative pain, neuropathic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

Transversus abdominis plane block with 20 ml saline

Arm Type

Placebo Comparator

Arm Description

Transversus abdominis plane block with 20 ml saline

Intervention Type

Procedure

Intervention Name(s)

Transversus abdominis plane block

Intervention Description

ultrasound guided transversus abdominis plane block

Primary Outcome Measure Information:

Title

Pain scores at rest and with movement using the numerical rating scale (NRS)

Time Frame

3, 6 and 24 hours postoperatively

Secondary Outcome Measure Information:

Title

Incidence of chronic pain

Time Frame

6 months after surgery

Other Pre-specified Outcome Measures:

Title

Morphine consumption (mg)

Time Frame

24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erifyli Argyra, MD, PhD

Organizational Affiliation

Aretaieion University Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kassiani Theodoraki, MD, PhD

Organizational Affiliation

Aretaieion University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aretaieion University Hospital

City

Athens

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

23160979

Citation

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.

Results Reference

result

PubMed Identifier

23549122

Citation

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.

Results Reference

result

Links:

URL

http://WWW.NYSORA.COM

Description

THE JOURNAL OF THE NEW YORK SCHOOL OF REGIONAL ANESTHESIA

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Transversus Abdominis Plane Block and Inguinal Hernia Repair

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