Transversus Abdominis Plane Block and Inguinal Hernia Repair

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030223
• Other study ID #: PAM-2345-1786
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: February 16, 2018
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Wall Muscles
• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• Transversus abdominis plane block
ultrasound guided transversus abdominis plane block

Locations

Country	Name	City	State
Greece	Aretaieion University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Papacharalampous Panagiota

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi — View Citation

Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morphine consumption (mg)		24 hours postoperatively
Primary	Pain scores at rest and with movement using the numerical rating scale (NRS)		3, 6 and 24 hours postoperatively
Secondary	Incidence of chronic pain		6 months after surgery

External Links

•   THE JOURNAL OF THE NEW YORK SCHOOL OF REGIONAL ANESTHESIA