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SUBLIME study: patient controlled sublingual sufentanil tablets versus intravenous morphine to enhance the quality of recovery after laparoscopic donor nephrectomy.

SUBLIME study: patient controlled sublingual sufentanil tablets versus intravenous morphine to enhance the quality of recovery after laparoscopic donor nephrectomy. - SUBLIME study

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46204
Enrollment
80
Registered
2019-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Pain management after laparoscopic donor nephrectomy / keyhole surgery to remove a kidney

Interventions

Patients will be randomly assigned in a 1:1 fashion to postoperative pain management with patient controlled sublingual sufentanil tablets or patient controlled intravenous morphine.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Scheduled for living kidney donation * Obtained informed consent * Age *18 years

Exclusion criteria

Exclusion criteria: * Inability to understand or follow instructions of use * Contra-indications for patient controlled analgesia or opiates * Chronic use of opiates * Moderate to severe liver insufficiency (Child-Pugh score * 7) * Severe renal insufficiency (eGFR 35 kg/m2

Design outcomes

Primary

MeasureTime frame
Independent mobilization (defined as patient reported use of the ward corridor bathroom without assistance) on postoperative day 1.

Secondary

MeasureTime frame
Quality of recovery on postoperative day 1 (QoR-40 questionnaire), quantitative mobilization measurements (HealthPatch® measured body posture and number of steps), heart rate variability, pain scores, postoperative nausea and vomiting, total dose of analgesics and anti-emetics, drug side effects, postoperative complications, length of hospital stay, re-admission within 30 days, ease of care nurse questionnaire and global daily cost of care.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)