Injections, Spinal, Morphine, Patient Satisfaction, Prostatectomy
Conditions
Brief summary
This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy
Detailed description
This study is a randomized controlled trial. It will randomize 160 patients who are scheduled for Robot-Assisted Radical Prostatectomy. The intervention group will receive a single spinal injection of a bupivacaine (12,5 mg)/morphine(300 mcg) mixture. Controlgroup will receive a subcutaneous injection of lidocaïne for placebo purposes and an intravenous loading dose of morphine at the end of surgery. Both groups will receive general anesthesia during surgery in a standardized fashion. After the surgery, both groups will receive a Patient-Controlled Analgesia pump for post-operative pain control. Primary outcome is patient satisfaction as measured by the Quality-of-Recovery-15 questionnaire. This questionnaire will be taken at baseline, day 2 and 1 week after surgery. Secundary outcomes are morphine use per PCA, duration of hospital stay, side-effects and ease of surgery.
Interventions
mixed with bupivacaine
sham procedure (s.c. lidocaïne)
Sponsors
Study design
Eligibility
Inclusion criteria
* Scheduled for Robot-Assisted Radical Prostatectomy
Exclusion criteria
* Contra-indications to spinal anesthesia (severe aortic stenosis, coagulation disorders) * Contra-indications to study medication (local anesthetics, morphine, paracetamol, metamizol) * Conversion to an open procedure * Post-operative ICU-admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | day 1 | Quality of Recovery-15 questionnaire |
Countries
Netherlands