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NCT Number: NCT02030223

Transversus Abdominis Plane Block and Inguinal Hernia Repair

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.

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Key information

Conditions

Inguinal Hernia Abdominal Wall Muscles Hernia Hernia, Abdominal Hernia, Inguinal Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Postoperative Pain Regional Anesthesia Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieion University Hospital

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversus abdominis plane block

Procedure

ultrasound guided transversus abdominis plane block

Primary outcomes

  1. Pain scores at rest and with movement using the numerical rating scale (NRS)

    Time frame: 3, 6 and 24 hours postoperatively

Secondary outcomes

  1. Incidence of chronic pain

    Time frame: 6 months after surgery

Other outcomes

  1. Morphine consumption (mg)

    Time frame: 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Papacharalampous Panagiota

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2014
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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