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Transversus Abdominis Plane Block and Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT02030223
Recruitment Status : Unknown
Verified January 2015 by Papacharalampous Panagiota, Aretaieion University Hospital.
Recruitment status was:  Recruiting
First Posted : January 8, 2014
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Abdominal Wall Muscles Regional Anesthesia Postoperative Pain Procedure: Transversus abdominis plane block Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of the Ultrasound Guided Transversus Abdominis Plane Block After Inguinal Hernia Repair With a Mesh.
Study Start Date : January 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Pain scores at rest and with movement using the numerical rating scale (NRS) [ Time Frame: 3, 6 and 24 hours postoperatively ]

Secondary Outcome Measures :
  1. Incidence of chronic pain [ Time Frame: 6 months after surgery ]

Other Outcome Measures:
  1. Morphine consumption (mg) [ Time Frame: 24 hours postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030223


Contacts
Contact: Panagiota Papacharalampous 00306974357660 pamy_papa@hotmail.com

Locations
Greece
Aretaieion University Hospital Recruiting
Athens, Greece
Sponsors and Collaborators
Papacharalampous Panagiota
Investigators
Study Chair: Erifyli Argyra, MD, PhD Aretaieion University Hospital
Principal Investigator: Kassiani Theodoraki, MD, PhD Aretaieion University Hospital
More Information

Additional Information:
Publications:
Responsible Party: Papacharalampous Panagiota, Anesthesiologist, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT02030223     History of Changes
Other Study ID Numbers: PAM-2345-1786
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Papacharalampous Panagiota, Aretaieion University Hospital:
transversus abdominis plane block
inguinal hernia repair
acute postoperative pain
neuropathic pain

Additional relevant MeSH terms:
Pain, Postoperative
Hernia
Hernia, Inguinal
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pathological Conditions, Anatomical
Hernia, Abdominal