Post-Operative Pain prevention after hepato-pancreato-biliary surgery: continuous sUbfascial infiltration orePidural analgesia? a randomized controlled non-inferiority multicenter trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23043

Enrollment

102

Registered

2015-01-02

Start date

2014-01-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-operative pain wound infiltration wound catheter OBAS epidural hepato-pancreato-biliairy surgery hpb surgery wondkatheters pancreas chirurgie lever chirurgie galweg chirurgie

Interventions

Intervention: Continuous subfascial wound infiltration+PCA Control: PCEA

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The primary endpoint is the Overall Benefit of Analgesic Score (OBAS) on day 1-5.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactTimothy Mungroop

AMC

t.h.mungroop@amc.nl0031 6 22 14 64 88

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

Post-Operative Pain prevention after hepato-pancreato-­biliary surgery: continuous sUbfascial infiltration orePidural analgesia? a randomized controlled non-­inferiority multicenter trial