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

A randomised, double blind clinical trial comparison the effect of a ultrasound-guided transversus abdominis plane (TAP) block and wound infiltration on postoperative pain (48h) for open inguinal hernia repair in day-care - TAP-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002595-82-NL

Enrollment

Unknown

Registered

2014-08-07

Start date

2014-10-23

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after hernia inguinalis repair surgery MedDRA version: 17.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Chirocaïne Product Name: Levobupivacaine Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Levobupivacaine CAS Number: 27262-48-2 Other descriptive name: LEV

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

Measure	Time frame
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 home, patient satisfaction en the incidence of nausea and vomiting.;Timepoint(s) of evaluation of this end point: After 30 patients	—

Countries

Netherlands

Contacts

Public Contactoperatieafdeling, vakgroep anesthes

Westfriesgasthuis

0031229855427

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026