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Transversus Abdominis Plane Block and Inguinal Hernia Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Papacharalampous Panagiota, Aretaieion University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02030223
First Posted: January 8, 2014
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Papacharalampous Panagiota, Aretaieion University Hospital
  Purpose
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 Intervention Phase
Inguinal Hernia Abdominal Wall Muscles Regional Anesthesia Postoperative Pain Procedure: Transversus abdominis plane block Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Papacharalampous Panagiota, Aretaieion University Hospital:

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

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

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

Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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 Submitted: January 7, 2014
First Posted: January 8, 2014
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:
Hernia
Pain, Postoperative
Hernia, Inguinal
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hernia, Abdominal