Postoperatieve pijnbehandeling middels continue epidurale toediening van bupivacaïne/sufentanil versus bupivacaïne/morfine bij patiënten na een grote chirurgische ingreep.

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 bupivacaïne 2.5 mg/ml + morphine 0.08 mg/ml or bupivacaïne 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.

Hypothesis to be tested (null hypothesis):

A continuous epidural infusion of bupivacaïne/sufentanil is equal to bupivacaïne/morphine in patients undergoing major surgery in terms of analgesia and side effects.

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 .

Patients are randomly assigned in two treatment groups:

1. Bupivacaïne 2.5 mg/ml + morphine 0.08 mg/ml (group BM);

2. Bupivacaïne 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 bupivacaïne with morphine (BM) 4-6 ml/hr or bupivacaïne 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 patient’s 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 NSAIDS’s at any time during the study.

If there is any doubt concerning the correct position of the epidural catheter 4-6 ml lidocaïne 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.