postoperatieve pijn Postoperative pain
Conditions
Interventions
The anesthetics (type and dose) given during general anesthesia will be left to
the discretion of the attending anesthesiologist and/or resident.
Patients randomized to the epidural group will recei
6-10 mL/h
with the possibility of giving an additional bolus). In the PACU
(recovery/ward) pain will be assessed using the 11-point numerical rating scale
(NRS
from 0, no pain to 10, most extreme pain imaginable) at regular
intervals. In case of pain score > 4, epidural bolus infusions will be
permitted and the patient controlled epidural analgesia (PCEA 1
from 0, no pain to 10, most
extreme pain imaginable). In case of pain score > 4, an opiate will be given
according to local protocol. When pain scores are 4 or less, the SST system
will be started.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: ASA class 1-3 patients, aged 18 and older that will undergo an elective pancreaticoduodenectomy under general anesthesia.
Exclusion criteria
Exclusion criteria: Patients that are unable to give written informed consent. Patients with a contra-indication for intravenous morphine, epidural analgesia or sublingual sufentanil (e.g. allergies, coagulopathies etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main end-point of the study will be *mean pain score during postoperative day 1-3 and mean day pain satisfaction on day 1-3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean daily pain scores beyond day 3 (day 0-dicharge) - Mean daily satisfaction scores beyond day 3 (day 0-dicharge) - Hemodynamics during and following surgery - Overall Benefin of Analgesia Score day 1, 2 en 3 - Blood loss - Surgery time - Anesthesia time - Anesthetics used during surgery (propofol/sevoflurane/ketamine, remifentanil/ sufentanil, rocuronium/sugammadex) - Vasoactive medication during an following surgery (noradrenaline/phenylephrine/ephedrine/atropine) - Fluid balances and weight during peri- and postoperative period - Duration of postoperative analgesia treatment (IV PCA M, EA and SST) - Rescue pain medication (reason, type, dose and duration) - Occurrence of nausea, vomiting, pruritis. - Complications during surgery (anesthetic and surgical complications) - General postoperative complications (e.g. anastomotic leakage, infectious complications) - Pancreatic surgery specific complications as defined by the International Study Group of Pancreatic Surgery (Postoperative Pancreatic Fistula, Postpancreatectomy Hemorrhage, Bile Leakage, Delayed Gastric Emptying, Chyle Leak) - Reinterventions/Clavien-Dindo classification - Laboratory findings during peri- and postoperative period - Unplanned (re)admission to the ICU - PACU stay/ICU stay/hospital stay - Unplanned 30-day hospital readmission - Mortality within 30-days. | — |
Countries
Netherlands
Outcome results
None listed