The objective of this study is to determine, whether the use of an perioperative echo guided unilateral TAP block has an superior effect onpostoperative 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 of bi-lateral TAP block is standard
hospita! care.
Maelsonstraat 3
Hoorn 1624NP
NL
Maelsonstraat 3
Hoorn 1624NP
NL
Listed location countries
Age
Inclusion criteria
age between 18-80, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35
Exclusion criteria
fever, a coagulation disorder (based on case history and pre-operative assessment questionary) , patiënts with kidney and or liver faillure (based on case history and pre-operative assessment questionary), an infection at the place by the puncture place, preoperative use of narcotics, NSAID's or paracetamol
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002595-82-NL |
| CCMO | NL49853.094.14 |
| OMON | NL-OMON25473 |