Hernia Inguinal
Conditions
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
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.
Interventions
PROCEDURETAP 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)
Sponsors
Dijklander Ziekenhuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| time to to first use of intravenous morfine | 48 hours |
| the total amount of titrated postoperative morfine | 48 hours |
| use of tramadol at home | 48 hours |
| patient satisfaction | 48 hours |
| the incidence of nausea and vomiting | 48 hours |
Countries
Netherlands
Outcome results
None listed