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Transversus Abdominis Plane Block and Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT02030223
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Papacharalampous Panagiota, Aretaieion University Hospital

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 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
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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



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 ]


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Ages Eligible for Study:   18 Years to 80 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

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


Locations
Greece
Aretaieion University Hospital
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

Additional Information:
Publications of Results:
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: February 19, 2018
Last Verified: February 2018

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