NCT02924974

Spinal Morphine in Robotic Assisted Radical Prostatectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Maasstad Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Morphine
• Injections, Spinal
• Prostatectomy
• Patient Satisfaction

Interventions

Type	Name	Description
DRUG	Morphine	mixed with bupivacaine
DRUG	Lidocaine	sham procedure (s.c. lidocaïne)

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-05-25
• Completion: 2018-08-06
• First posted: 2016-10-05
• Last updated: 2018-08-07

Locations

1 site across 1 country: Netherlands