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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02924974
Date of registration:	29/09/2016
Prospective Registration:	No
Primary sponsor:	Maasstad Hospital
Public title:	Spinal Morphine in Robotic Assisted Radical Prostatectomy SALMON-RARP
Scientific title:	Spinal Morphine in Robotic Assisted Radical Prostatectomy
Date of first enrolment:	September 2016
Target sample size:	160
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02924974
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Netherlands

Contacts

Name:	Aart Jan W Teunissen, MD
Address:
Telephone:
Email:
Affiliation:	Maasstad Ziekenhuis

Name:	Seppe Koopman, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Maasstad Ziekenhuis

Name:	Mark V Koning, MD, DESA
Address:
Telephone:
Email:
Affiliation:	Maasstad Ziekenhuis

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatectomy

Injections, Spinal

Morphine

Patient Satisfaction

Intervention(s)

Drug: Morphine

Drug: Lidocaine

Primary Outcome(s)

Patient satisfaction [Time Frame: day 1]

Secondary Outcome(s)

Secondary ID(s)

L2015108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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