Spinal Morphine in Robotic Assisted Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-08-06

Brief Summary

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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

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Detailed Description

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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

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Morphine Injections, Spinal Prostatectomy Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

subcutaneous lidocaïne and intravenous loading dose of morphine

Group Type SHAM_COMPARATOR

Lidocaine

Intervention Type DRUG

sham procedure (s.c. lidocaïne)

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

mixed with bupivacaine

Interventions

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Morphine

mixed with bupivacaine

Intervention Type DRUG

Lidocaine

sham procedure (s.c. lidocaïne)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No