Intrathecal Morphine in Robot-assisted Prostatectomy (RoboITMProst)

Seoul National University

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Drug: The intrathecal morphine injection; Drug: The intravenous patient-controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01991275

ITMRoboProstDMHong

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

The ITM group

Experimental group

Description:

The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.

Treatment:

Drug: The intrathecal morphine injection

Drug: The intravenous patient-controlled analgesia

The IV-PCA group

Placebo Comparator group

Description:

The postoperative pain management includes only the intravenous patient-controlled analgesia.

Treatment:

Drug: The intravenous patient-controlled analgesia