Post-Operative Pain prevention after hepato-pancreato-biliary surgery: continuous sUbfascial infiltration or ePidural analgesia? a randomized controlled non-inferiority multicenter trial
Phase 4
Completed
- Conditions
- post-operative painpost-operative pain after HPB- operations1001965410017998
- Registration Number
- NL-OMON42243
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
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
- 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 <80
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Overall benefit of analgesic score (OBAS score). Measured on postoperative day<br /><br>1-5.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Total operative time. (operation time / pre-operative time)<br /><br>- Length of hospital stay / readiness for discharge<br /><br>- Failure of analgesic technique<br /><br>- Pain after 12/24/72 hours, during rest and movement (VAS score)<br /><br>- Cumulative opioid consumption<br /><br>- Hypotension with the need for additional fluid boluses during and after<br /><br>surgery and noradrenaline dependency<br /><br>- Days CSWI/PCEA needed<br /><br><br /><br>Side effects up to 30 days, including:<br /><br>- Prolonged post-anaesthesia care unit / Intensive care unit stay<br /><br>- Duration of indwelling urinary catheter (days)<br /><br>- Pruritus, post-operative nausea and vomiting<br /><br>- Complications related to anaesthetic technique, f.e. CNS toxicity, epidural<br /><br>hematoma, epidural abscess, wound infection<br /><br>- Post-surgical pain after 30 days</p><br>