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

D

Dijklander Ziekenhuis

Status

Unknown

Conditions

Hernia Inguinal

Treatments

Procedure: TAP block

Study type

Interventional

Funder types

Other

Identifiers

NCT01793571
NL40460.094.12

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

TAP block
Experimental group
Description:
20 ml Levobupivacaine 0,5%
Treatment:
Procedure: TAP block
Local wound infiltration
Active Comparator group
Description:
20 ml levobupivacaine 0,5%
Treatment:
Procedure: TAP block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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