A trial on comparison the effect of a TAP-blok and wound-infiltration on pain after inguinal hernia repair surgery

Phase 1

Conditions: Postoperative pain after hernia inguinalis repair surgery
MedDRA version: 17.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-002595-82-NL

Lead Sponsor: Westfriesgasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

age between 18-80, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

fever, a coagulation disorder, patiënts with kidney and or liver faillure, an infection at the place by the puncture place, preoperative use of narcotics and NSAID's

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation.;Secondary Objective: Time to the first use of intravenous Morfine, the total amount of titrated postoperative Morfine, use of Tramadol at<br> home, patient satisfaction en the incidence of nausea and vomiting.;Primary end point(s): Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation.;Timepoint(s) of evaluation of this end point: After 30 patients

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary objectives are; time to to first use of intravenous Morfine, the total amount of titrated postoperative Morfine, use of Tramadol at<br>home, patient satisfaction en the incidence of nausea and vomiting.;Timepoint(s) of evaluation of this end point: After 30 patients