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

Dijklander Ziekenhuis30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hernia Inguinal

Interventions

TAP blockPROCEDURE

2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Westfriesgasthuis

Hoorn, North Holland, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

time to to first use of intravenous morfine

Time frame: 48 hours

the total amount of titrated postoperative morfine

Time frame: 48 hours

use of tramadol at home

Time frame: 48 hours

patient satisfaction

Time frame: 48 hours

the incidence of nausea and vomiting

Time frame: 48 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.