Trial record 12 of 65 for:    Open Studies | "Hernia, Inguinal"

Transversus Abdominis Plane Block and Inguinal Hernia Repair

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Aretaieion University Hospital
Sponsor:
Information provided by (Responsible Party):
Papacharalampous Panagiota, Aretaieion University Hospital
ClinicalTrials.gov Identifier:
NCT02030223
First received: January 7, 2014
Last updated: February 11, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of chronic pain [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Morphine consumption (mg) [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030223

Contacts
Contact: Panagiota Papacharalampous 00306974357660 pamy_papa@hotmail.com

Locations
Greece
Aretaieion University Hospital Not yet 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
Study First Received: January 7, 2014
Last Updated: February 11, 2014
Health Authority: Greece: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014