No registrations found.
ID
Source
Brief title
Health condition
post-operative pain
wound infiltration
wound catheter
OBAS
epidural
hepato-pancreato-biliairy surgery
hpb surgery
wondkatheters
pancreas chirurgie
lever chirurgie
galweg chirurgie
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the Overall Benefit of Analgesic Score (OBAS) on day 1-5.
Secondary outcome
Total operative time (recorded as total time spent in the operating room, anaesthetic time, surgical time), length of hospital stay / readiness for discharge, failure of analgesic technique, pain every 12 hours until discharge at rest and movement
(VAS scores), cumulative opioid consumption, days CSWI/PCEA needed.
Side effects up to 30 days, including:
- Hypotension with the need for additional fluid boluses during and after
surgery and noradrenaline dependency
Both at the end of surgery and at the end of PACU stay we will record:
1 duration of noradrenaline dependency and cumulative consumption
2 fluid boluses administered
3 fluid balance
- Prolonged post-anaesthesia care unit / Intensive care unit stay
- Duration of indwelling urinary catheter (yes/no) per day
- Pruritus, post-operative nausea and vomiting
- Complications related to anaesthetic technique, like CNS toxicity, epidural
hematoma, epidural abscess
- Post-surgical pain after 30 days, 6 months and 12 months
- Existing pain? If yes, VAS?
- plasma levels in 20 patients after bolus injection.
Background summary
NA
Study objective
Post-operative pain prevention with CSWI+PCA provides similar analgesia (measured by
OBAS) in comparison to PCEA with shorter total operation time and shorter length of hospital
stay.
Study design
day 1-5, 6, 12 months
Intervention
Intervention: Continuous subfascial wound infiltration+PCA
Control: PCEA
Inclusion criteria
Inclusion criteria
- Patients of 18 years and older
- Elective laparotomy for hepato-pancreato-biliary conditions:
„X Pylorus preserving pancreatoduodenectomy (PPPD), Whipple procedure
„X Distal pancreatectomy
„X Hepatojejunostomy
„X Partial liver resection
„X Other hepato-pancreato-biliary laparotomies (elective)
- Patients who have signed an informed consent form
Exclusion criteria
- ASA status >3
- Chronic opioid use (>12 months) and not for the indication of this operation
- Allergy to local anesthetics or morphine
- Renal / Liver failure
- Contraindications for epidural placement
- INR >1.5, PPT>1.5, Platelets <80
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL4825 |
| NTR-old | NTR4948 |
| Other | POP-UP RCT : POP-UP trial |