Intrathecal Morphine in Robot-assisted Prostatectomy (RoboITMProst)

July 1, 2015 updated by: Deok Man Hong, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The ITM group
The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.
Drug: The intrathecal morphine injection
A single injection of morphine intrathecally
Drug: The intravenous patient-controlled analgesia
The intravenous injection of morphine using the patient-controlled analgesia machine
PLACEBO_COMPARATOR: The IV-PCA group
The postoperative pain management includes only the intravenous patient-controlled analgesia.
Drug: The intravenous patient-controlled analgesia
The intravenous injection of morphine using the patient-controlled analgesia machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of pain at 24 hours after surgery
Time Frame: 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.
at postoperatively 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The consumption of analgesics
Time Frame: at postoperatively 24 hours
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
Time Frame: 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.
From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours
The side effects of opioids after surgery
Time Frame: 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.
During 72 hours after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITMRoboProstDMHong

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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