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

Phase 4

Withdrawn

Conditions: Pain management after laparoscopic donor nephrectomy / keyhole surgery to remove a kidney
10038365

Registration Number: NL-OMON46204

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

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

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 <30ml/min/1,73 m2)
* Known or suspected allergy to morphine, sufentanil or one of the additives
* Signs of increased intracranial pressure, recent head injury or brain tumor.
* Biliary obstructive disorders or acute pancreatitis
* Bradyarrhythmia
* BMI > 35 kg/m2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Independent mobilization (defined as patient reported use of the ward corridor<br /><br>bathroom without assistance) on postoperative day 1.</p><br>

Secondary Outcome Measures

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