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Spinal Morphine in Robotic Assisted Radical Prostatectomy

Spinal Morphine in Robotic Assisted Radical Prostatectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02924974
Acronym
SALMON-RARP
Enrollment
160
Registered
2016-10-05
Start date
2016-09-30
Completion date
2018-08-06
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injections, Spinal, Morphine, Patient Satisfaction, Prostatectomy

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

DRUGMorphine

mixed with bupivacaine

DRUGLidocaine

sham procedure (s.c. lidocaïne)

Sponsors

Maasstad Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Patient satisfactionday 1Quality of Recovery-15 questionnaire

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026