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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
Sponsored by
Papacharalampous Panagiota
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 7, 2014
Last Updated
February 16, 2018
Sponsor
Papacharalampous Panagiota
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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
No
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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