-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…
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Primary objective is to analyse, differences in pain scores between the 2
groups until 48 hours after the operation.
Secondary outcome
-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.
Background summary
-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 insufficiant treatment of postoperative pain is a risk
factor for persistant or chronic pain after open inguinal hernia repair.
Chronic pain is not uncommon after hernia repair, with an incidence of 11%.
Study objective
-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.
Study design
- An prospective double blinded randomised trial.
Intervention
-Perioperative echo guided TAP block.
Study burden and risks
-The use of the echo-guided unilateral TAP block is standard hospital care.
Maelsonstraat 3 3
Hoorn 1624NP
NL
Maelsonstraat 3 3
Hoorn 1624NP
NL
Listed location countries
Age
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, patiënts with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and NSAID's,
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-001837-15-NL |
| CCMO | NL40460.094.12 |