- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924974
Spinal Morphine in Robotic Assisted Radical Prostatectomy (SALMON-RARP)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Rotterdam, Netherlands
- Maasstad Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control
subcutaneous lidocaïne and intravenous loading dose of morphine
|
sham procedure (s.c.
lidocaïne)
|
Experimental: Intervention
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: day 1
|
Quality of Recovery-15 questionnaire
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Morphine
Other Study ID Numbers
- L2015108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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