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Pijnstilling na verwijdering van de alvleesklierkop: Een multicenter onderzoek in Nederland


- candidate number29091
- NTR NumberNTR7318
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jun-2018
- Secondary IDsNL64936.058.18 ABR dossier nummer /  P18.061 Commissie Medische Ethiek Leids Universitair Medisch Centrum
- Public TitlePijnstilling na verwijdering van de alvleesklierkop: Een multicenter onderzoek in Nederland
- Scientific TitlePostoperative pain relief following pancreaticoduodenectomy:
A multicenter strategy study in the Netherlands
- ACRONYMTriple P study
- hypothesisWe hypothesize SST to be an equi-effective (i.e., non-inferior) analgesic compared to EA in the treatment of postoperative pain and satisfaction with pain relief in PD patients.
- Healt Condition(s) or Problem(s) studiedPancreaticoduodenectomy, Postoperative pain relief
- Inclusion criteriaASA class 1-3 patients, aged 18 and older that will undergo an elective pancreaticoduodenectomy under general anesthesia.
- Exclusion criteriaPatients that are unable to give written informed consent. Patients with a contra-indication for EA or SST (e.g. allergies, coagulopathies), inability to operate the SST system, chronic opioid use, complex chronic pain disorders, liver failure.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2018
- planned closingdate1-aug-2020
- Target number of participants106
- InterventionsActive comparator: sublingual sufentanil tablets Passive comparator: epidural analgesia
- Primary outcomeMean pain score during postoperative day 1-3 and mean pain satisfaction score during postoperative day 1-3
- Secondary outcomeMean daily pain scores (day 0-dicharge).
Mean daily pain satisfaction scores beyond day 3 till discharge.
Number of patients reporting a NRS > 4 on day 1 till discharge.
Anesthesiological and surgical outcomes.
- TimepointsPlanned start 01-08-2018
Planned closing 31-12-2019
Planned publication 01-08-2020
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIES J.V. Groen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryIn the current study we will assess the postoperative pain scores following two techniques that are currently considered standard-of-care in our hospitals:
- EA (thoracic epidural catheter placed before surgery; patient controlled epidural analgesia following surgery).
- Patient controlled administration of SST (15 μg) following an intraoperative morphine bolus and titration with morphine boluses upon recovery to a pain score of 4 or less.
- Main changes (audit trail)
- RECORD27-jun-2018 - 9-jul-2018


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