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Spinal Morphine in Robotic Assisted Radical Prostatectomy (SALMON-RARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924974
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Maasstad Hospital

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

Condition or disease Intervention/treatment Phase
Morphine Injections, Spinal Prostatectomy Patient Satisfaction Drug: Morphine Drug: Lidocaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control
subcutaneous lidocaïne and intravenous loading dose of morphine
Drug: Lidocaine
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
Drug: Morphine
mixed with bupivacaine




Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: day 1 ]
    Quality of Recovery-15 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Sponsors and Collaborators
Maasstad Hospital
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maasstad Hospital
ClinicalTrials.gov Identifier: NCT02924974    
Other Study ID Numbers: L2015108
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Lidocaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics