Skip to main content
OpenTrials
Completed

NCT Number: NCT02924974

Spinal Morphine in Robotic Assisted Radical Prostatectomy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morphine Behavior Health Behavior Injections, Spinal Patient Satisfaction Prostatectomy Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Maasstad Hospital

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

mixed with bupivacaine

Lidocaine

Drug

sham procedure (s.c. lidocaïne)

Primary outcomes

  1. Patient satisfaction

    Time frame: day 1

    Quality of Recovery-15 questionnaire

Sponsors and collaborators

Lead sponsor

Maasstad Hospital

Other

Registry information

Acronym: SALMON-RARP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.