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


- candidate number21207
- NTR NumberNTR4948
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jan-2015
- Secondary IDsPOP-UP trial POP-UP RCT
- Public TitlePost-Operative Pain prevention after hepato-pancreato-­biliary surgery: continuous sUbfascial infiltration orePidural analgesia? a randomized controlled non-­inferiority multicenter trial
- Scientific TitlePost-Operative Pain prevention after hepato-pancreato-­biliary surgery: continuous sUbfascial infiltration orePidural analgesia? a randomized controlled non-­inferiority multicenter trial
- ACRONYMPOP-UP
- hypothesisPost-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.
- Healt Condition(s) or Problem(s) studiedPost-operative pain, Wound infection, Epidural analgesia, wound catheter, OBAS
- Inclusion criteriaInclusion 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jan-2014
- planned closingdate1-sep-2016
- Target number of participants102
- InterventionsIntervention: Continuous subfascial wound infiltration+PCA Control: PCEA
- Primary outcomeThe primary endpoint is the Overall Benefit of Analgesic Score (OBAS) on day 1-5.
- Secondary outcomeTotal 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?
- Timepointsday 1-5, 6, 12 months
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMC Timothy Mungroop
- CONTACT for SCIENTIFIC QUERIESMD PhD Marc G.H. Besselink
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)28-okt-2016: Amendment

Secondary outcomes:
- plasma levels in 20 patients after bolus injection.
- RECORD2-jan-2015 - 28-okt-2016


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