Clinical trial NCT01793571: Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair
Official title: A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia Inguinal
Keywords: Abdominal Muscles/Ultrasonography
Adult
Ambulatory Surgical Procedures
Anesthetics, Local/Administration & Dosage
Levobupivacaine/Administration & Dosage
Levobupivacaine/Analogs & Derivatives
Hernia, Inguinal/Surgery
Humans
Nerve Block/Methods
Pain Measurement/Methods
Pain, Postoperative/Prevention & Control
Ultrasonography, Interventional
Lead sponsor: Dijklander Ziekenhuis
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation
timeFrame: 48 hours
Secondary outcomes:
measure: time to to first use of intravenous morfine
timeFrame: 48 hours
measure: the total amount of titrated postoperative morfine
timeFrame: 48 hours
measure: use of tramadol at home
timeFrame: 48 hours
measure: patient satisfaction
timeFrame: 48 hours
measure: the incidence of nausea and vomiting
timeFrame: 48 hours
Other outcomes:
Locations:
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis
state: Noord-Holland
Study officials:
affiliation: Dijklander Ziekenhuis
name: Jens P Hering, Anesthesiologist
role: PRINCIPAL_INVESTIGATOR
References: