Overview

This trial is active, not recruiting.

Condition hernia inguinal
Treatment tap block
Sponsor Westfriesgasthuis
Start date September 2012
End date March 2013
Trial size 30 participants
Trial identifier NCT01793571, NL40460.094.12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
20 ml Levobupivacaine 0,5%
tap block
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)
(Active Comparator)
20 ml levobupivacaine 0,5%
tap block
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)

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
Principal investigator Jens P Hering, Anesthesiologist
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Westfriesgasthuis.