Intrathecal Morphine in Robot-assisted Prostatectomy

Prostatic Neoplasms Clinical Trial

— RoboITMProst  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991275
• Other study ID #: ITMRoboProstDMHong
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: July 1, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• The intravenous patient-controlled analgesia
The intravenous injection of morphine using the patient-controlled analgesia machine
• The intrathecal morphine injection
A single injection of morphine intrathecally

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes