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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22506
Enrollment
424
Registered
2009-01-11
Start date
2009-02-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epidural, bupivacaïne, sufentanil, morphine, analgesia, side effects Epiduraal, morfine, analgesie, bijwerkingen

Interventions

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

Sponsors

UMCU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older; 2. Scheduled major surgery; 3. Indication for epidural catheter according to the responsible anaesthesiologist.

Exclusion criteria

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; 5. Pregnancy.

Design outcomes

Primary

MeasureTime frame
The pain scores during the first 72 hours after surgery.

Secondary

MeasureTime frame
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.

Contacts

Public ContactA.M. Karsch

Divisie Peri-operatieve Zorg en Spoedeisende Hulp (DP&S), Universitair Medisch Centrum Utrecht

+31 (0)88-75 59216

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)