Intrathecal Morphine in Robot-assisted Prostatectomy

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: The intravenous patient-controlled analgesia; Drug: The intrathecal morphine injection

• Registration Number: NCT01991275
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The ITM group	The intravenous patient-controlled analgesia	The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.
The IV-PCA group	The intravenous patient-controlled analgesia	The postoperative pain management includes only the intravenous patient-controlled analgesia.
The ITM group	The intrathecal morphine injection	The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.

Primary Outcome Measures

Name	Time	Method
The evaluation of pain at 24 hours after surgery	at postoperatively 24 hours	The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University of Hospital; 🇰🇷 Seoul, Korea, Republic of