Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair

Not Applicable

• Conditions: Hernia Inguinal
• Interventions: Procedure: TAP block

• Registration Number: NCT01793571
• Lead Sponsor: Dijklander Ziekenhuis

Brief Summary

An prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.

Detailed Description

Hernia inguinal repair is the most common operation performed by general surgeons in the Netherlands. On of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open inguinal hernia repair. Chronic pain is not uncommon after hernia repair, with an incidence of 11%.

The objective of this study is to determine, whether the use of an perioperative echo guided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. There will be no further analysis in this study regarding the incidence of open hernia inguinal repair and chronic pain.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-01-17
• Status Verified: 2013-02
• Study First Submitted QC: 2013-02-14
• Last Update Submitted: 2013-02-14
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• age between 18 and 80 year, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35.

Exclusion Criteria

• fever, a coagulation disorder, patients with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and nonsteroidal antiinflammatory drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block	TAP block	20 ml Levobupivacaine 0,5%
Local wound infiltration	TAP block	20 ml levobupivacaine 0,5%

Primary Outcome Measures

Name	Time	Method
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation	48 hours

Secondary Outcome Measures

Name	Time	Method
time to to first use of intravenous morfine	48 hours
the total amount of titrated postoperative morfine	48 hours
use of tramadol at home	48 hours
patient satisfaction	48 hours
the incidence of nausea and vomiting	48 hours

Trial Locations

Locations (1)

Westfriesgasthuis; 🇳🇱 Hoorn, Noord-Holland, Netherlands