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

Maasstad Hospital

Status and phase

Completed

Phase 4

Conditions

Morphine

Prostatectomy

Injections, Spinal

Patient Satisfaction

Treatments

Drug: Morphine

Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02924974

L2015108

Details and patient eligibility

About

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

Full 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.

Enrollment

160 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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