Spinal Morphine in Robotic Assisted Radical Prostatectomy (SALMON-RARP)
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|ClinicalTrials.gov Identifier: NCT02924974|
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Morphine Injections, Spinal Prostatectomy Patient Satisfaction||Drug: Morphine Drug: Lidocaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Spinal Morphine in Robotic Assisted Radical Prostatectomy|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||May 25, 2018|
|Actual Study Completion Date :||August 6, 2018|
Sham Comparator: Control
subcutaneous lidocaïne and intravenous loading dose of morphine
sham procedure (s.c. lidocaïne)
Spinal injection of 4 or 5 ml of bupivacaine/morphine 2,5 mg/ml/60mcg/ml. The reduction to 4 ml is for patients over 75 years of age
mixed with bupivacaine
- Patient satisfaction [ Time Frame: day 1 ]Quality of Recovery-15 questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924974
|Study Chair:||Seppe Koopman, MD, PhD||Maasstad Ziekenhuis|
|Study Chair:||Aart Jan W Teunissen, MD||Maasstad Ziekenhuis|
|Principal Investigator:||Mark V Koning, MD, DESA||Maasstad Ziekenhuis|