Transversus Abdominis Plane Block and Inguinal Hernia Repair

February 16, 2018 updated by: Papacharalampous Panagiota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Aretaieion University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transversus abdominis plane block with 20 ml ropivacaine 0,75%
Procedure: Transversus abdominis plane block
ultrasound guided transversus abdominis plane block
Placebo Comparator: Transversus abdominis plane block with 20 ml saline
Procedure: Transversus abdominis plane block
ultrasound guided transversus abdominis plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain scores at rest and with movement using the numerical rating scale (NRS)
Time Frame: 3, 6 and 24 hours postoperatively
3, 6 and 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of chronic pain
Time Frame: 6 months after surgery
6 months after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Morphine consumption (mg)
Time Frame: 24 hours postoperatively
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papacharalampous Panagiota

Investigators

  • Study Chair: Erifyli Argyra, MD, PhD, Aretaieion University Hospital
  • Principal Investigator: Kassiani Theodoraki, MD, PhD, Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAM-2345-1786

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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