Spinal Morphine in Robotic Assisted Radical Prostatectomy

Phase 4

Completed

• Conditions: Morphine; Injections, Spinal; Prostatectomy; Patient Satisfaction
• Interventions: Drug: Lidocaine; Drug: Morphine

• Registration Number: NCT02924974
• Lead Sponsor: Maasstad Hospital

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

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Status Verified: 2018-03
• Primary Completion: 2018-05-25
• Study Completion: 2018-08-06
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Lidocaine	subcutaneous lidocaïne and intravenous loading dose of morphine
Intervention	Morphine	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

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	day 1	Quality of Recovery-15 questionnaire

Trial Locations

Locations (1)

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands