SALMON-RARP: Spinal Morphine in Robotic Assisted Radical Prostatectomy

• Sponsor: Maasstad Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02924974
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Duration (Months): 23.1
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Morphine; Injections, Spinal; Prostatectomy; Patient Satisfaction	Drug: Morphine; Drug: Lidocaine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Spinal Morphine in Robotic Assisted Radical Prostatectomy
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: May 25, 2018
• Actual Study Completion Date: Aug 6, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction [day 1]

   Quality of Recovery-15 questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maasstad Hospital	Rotterdam		Netherlands

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maasstad Hospital
• ClinicalTrials.gov Identifier: NCT02924974
• Other Study ID Numbers: L2015108
• First Posted: Oct 5, 2016
• Last Update Posted: Aug 7, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Lidocaine; Morphine

Study Results

No Results Posted as of Aug 7, 2018