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

Post-Operative Pain prevention after hepato-pancreato-biliary surgery: continuous sUbfascial infiltration or ePidural analgesia? a randomized controlled non-inferiority multicenter trial - POP-UP study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42243

Enrollment

102

Registered

2014-12-10

Start date

2015-01-21

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

post-operative pain post-operative pain after HPB- operations

Interventions

CSWI (Bupivacaine) After the incision 3x10ml bupivacaine 0.25% is injected at three locations in the space between peritoneum and posterior fascia. (total 30 ml) At the end of surgery wound catheter

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients of 18 years and older - Elective laparotomy for hepato-pancreato-biliary conditions: * Pylorus preserving pancreatoduodenectomy (PPPD), Whipple procedure * Distal pancreatectomy * Hepatojejunostomy * Partial liver resection * Other hepato-pancreato-biliary laparotomies (elective) - Patients who have signed an informed consent form

Exclusion criteria

Exclusion criteria: - ASA status 4 - Chronic opioid use - Allergy to local anesthetics or morphine - Renal / Liver failure - Contraindications for epidural placement - INR >1.5 , PPT>1.5, Platelets

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Overall benefit of analgesic score (OBAS score). Measured on postoperative day 1-5.	—

Secondary

Measure	Time frame
Secondary endpoints: - Total operative time. (operation time / pre-operative time) - Length of hospital stay / readiness for discharge - Failure of analgesic technique - Pain after 12/24/72 hours, during rest and movement (VAS score) - Cumulative opioid consumption - Hypotension with the need for additional fluid boluses during and after surgery and noradrenaline dependency - Days CSWI/PCEA needed Side effects up to 30 days, including: - Prolonged post-anaesthesia care unit / Intensive care unit stay - Duration of indwelling urinary catheter (days) - Pruritus, post-operative nausea and vomiting - Complications related to anaesthetic technique, f.e. CNS toxicity, epidural hematoma, epidural abscess, wound infection - Post-surgical pain after 30 days	—

Measure

Time frame

Secondary endpoints: - Total operative time. (operation time / pre-operative time) - Length of hospital stay / readiness for discharge - Failure of analgesic technique - Pain after 12/24/72 hours, during rest and movement (VAS score) - Cumulative opioid consumption - Hypotension with the need for additional fluid boluses during and after surgery and noradrenaline dependency - Days CSWI/PCEA needed Side effects up to 30 days, including: - Prolonged post-anaesthesia care unit / Intensive care unit stay - Duration of indwelling urinary catheter (days) - Pruritus, post-operative nausea and vomiting - Complications related to anaesthetic technique, f.e. CNS toxicity, epidural hematoma, epidural abscess, wound infection - Post-surgical pain after 30 days

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)