Intrathecal Morphine in Robot-assisted Prostatectomy

Study Overview
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Brief Summary
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This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy

Detailed Description
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Prostatectomy is the treatment of choice for prostate cancer. The robot-assisted prostatectomy is becoming the most popular surgical method for prostate cancer. The small incision after robot-assisted prostatectomy is thought to reduce the postoperative pain. There is few investigations for the strategy to reduce the postoperative pain of robot-assisted prostatectomy. The intrathecal morphine injection is known to reduce postoperative pain for surgeries like hepatectomy, myomectomy and open prostatectomy. This method, however, is not yet studied for the robot-assisted prostatectomy. This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy.

Official Title
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The Efficacy of Intrathecal Morphine in Patients Undergoing Robot-assisted Prostatectomy

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: The intravenous patient-controlled analgesia
* Drug: The intrathecal morphine injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for the open nephrectomy Exclusion Criteria: Patients with renal insufficiency Patients with coagulopathy History of any neurologic disorder History of recent infection in 2 weeks History of drug abuse Patients who cannot understand the usage of th intravenous patient-controlled analgesia Patients using opioids due to the chronic pain

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The ITM group<br>The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. | Drug: The intravenous patient-controlled analgesia<br>* The intravenous injection of morphine using the patient-controlled analgesia machine<br>Drug: The intrathecal morphine injection<br>* A single injection of morphine intrathecally<br>|
| Placebo Comparator: The IV-PCA group<br>The postoperative pain management includes only the intravenous patient-controlled analgesia. | Drug: The intravenous patient-controlled analgesia<br>* The intravenous injection of morphine using the patient-controlled analgesia machine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of pain at 24 hours after surgery | The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale. | at postoperatively 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The consumption of analgesics | The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared. | at postoperatively 24 hours | 
| The consumption of intraoperative opioids | The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared. | From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours | 
| The side effects of opioids after surgery | Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded. | During 72 hours after the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Laparoscopy, Injections, Spinal, Morphine