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NCT02924974 Clinical Trial

Spinal Morphine in Robotic Assisted Radical Prostatectomy

Patient Satisfaction Clinical Trial

— SALMON-RARP  

Official title:
Spinal Morphine in Robotic Assisted Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02924974
Other study ID # L2015108
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2016
Est. completion date August 6, 2018

Study information
Verified date March 2018
Source Maasstad Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date August 6, 2018
Est. primary completion date May 25, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Morphine
mixed with bupivacaine
• Lidocaine
sham procedure (s.c. lidocaïne)

Locations
Country Name City State
Netherlands Maasstad Hospital Rotterdam

Sponsors (1)
Lead Sponsor Collaborator
Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient satisfaction Quality of Recovery-15 questionnaire day 1
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