|- candidate number||5138|
|- NTR Number||NTR1622|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jan-2009|
|- Secondary IDs||NL19432.041.09 / 2007-005275-33 ; CCMO / EudraCT|
|- Public Title||Postoperatieve pijnbehandeling middels continue epidurale toediening van bupivaca´ne/sufentanil versus bupivaca´ne/morfine bij patiŰnten na een grote chirurgische ingreep.|
|- Scientific Title||Postoperative analgesia with continuous epidural bupivacaine/sufentanil versus bupivacaine/morphine in patients undergoing major surgery.|
|- hypothesis||Hypothesis to be tested (null hypothesis): |
A continuous epidural infusion of bupivaca´ne/sufentanil is equal to bupivaca´ne/morphine in patients undergoing major surgery in terms of analgesia and side effects.
|- Healt Condition(s) or Problem(s) studied||Patients who undergo major surgery|
|- Inclusion criteria||1. Age 18 years or older;|
2. Scheduled major surgery;
3. Indication for epidural catheter according to the responsible anaesthesiologist.
|- Exclusion criteria||1. Patients with an allergy to one of the study medications;|
2. Patients using opioids pre-operatively;
3. Patients who are not speaking Dutch;
4. Patients with mental disability;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||1-feb-2011|
|- Target number of participants||424|
|- Interventions||Patients are randomly assigned in two treatment groups:|
1. Bupivaca´ne 2.5 mg/ml + morphine 0.08 mg/ml (group BM);
2. Bupivaca´ne 2.5 mg/ml + sufentanil 1 ug/ml (group BS).
Before surgery a epidural catheter is inserted. After surgery patients are receiving either continuous epidural bupivaca´ne with morphine (BM) 4-6 ml/hr or bupivaca´ne with sufentanil (BS) 4-6 ml/hr. Both groups receive usual care, only the epidural mixture medication is different. Subjects will be not be allowed to see the study medication.
During the postoperative course residents from the department anaesthesiology adjust the infusion rate of the study medication once a day to the individual patientĺs requirement. The aim is to achieve a pain score of 4 or less and a dynamic pain score of 6 or less. Patients in both groups are permitted to take paracetamol and/or NSAIDSĺs at any time during the study.
If there is any doubt concerning the correct position of the epidural catheter 4-6 ml lidoca´ne 2% will be administered according to the protocol. If an adequate analgesic effect can not be achieved in the first 8 hours after the end of the operation, the patient is excluded from the trial.
|- Primary outcome||The pain scores during the first 72 hours after surgery. |
|- Secondary outcome||The quality of pain relief (as experienced by the patient) and side/adverse effects: pruritis, drowsiness, nausea, vomiting and/or motor block, sedation, respiratory depression and episodes of hypotension.|
|- Timepoints||The adequacy of analgesia will be assessed every 30 minutes in the recovery room and every hour during the first 4 hours postoperative and every 8 hours the next 72 hours. The quality of pain relief will be classified daily .|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.M. Karsch|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.M. Karsch|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Postoperative analgesia with continuous epidural bupivacaine/sufentanil versus bupivacaine/morphine in patients undergoing major surgery is compared in a double blind randomised clinical trial. The patients are randomised to either bupivaca´ne 2.5 mg/ml + morphine 0.08 mg/ml or bupivaca´ne 2.5 mg/ml + sufentanil 1 ug/ml. Primary outcome is the pain score on a Numerical Rating Scale (NRS) during the first 72 hours after surgery. Side-effects (pruritus, nausea and vomiting) and adverse effects (respiratory depression, sedation and motor block) are also recorded.|
|- Main changes (audit trail)|
|- RECORD||11-jan-2009 - 21-mrt-2010|