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

August 6, 2018 updated by: Maasstad Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
subcutaneous lidocaïne and intravenous loading dose of morphine
Drug: Lidocaine
sham procedure (s.c. lidocaïne)
Experimental: Intervention
Spinal injection of 4 or 5 ml of bupivacaine/morphine 2,5 mg/ml/60mcg/ml. The reduction to 4 ml is for patients over 75 years of age
Drug: Morphine
mixed with bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: day 1
Quality of Recovery-15 questionnaire
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maasstad Hospital

Investigators

  • Study Chair: Seppe Koopman, MD, PhD, Maasstad Ziekenhuis
  • Study Chair: Aart Jan W Teunissen, MD, Maasstad Ziekenhuis
  • Principal Investigator: Mark V Koning, MD, DESA, Maasstad Ziekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

May 25, 2018

Study Completion (Actual)

August 6, 2018

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2015108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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