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Intrathecal Morphine in Robot-assisted Prostatectomy (RoboITMProst)

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
The intravenous patient-controlled analgesia
The intrathecal morphine injection
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Laparoscopy, Injections, Spinal, Morphine

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University of Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The ITM group

The IV-PCA group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The consumption of analgesics
The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.
The consumption of intraoperative opioids
The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.
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.

Full Information

First Posted
November 18, 2013
Last Updated
July 1, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01991275
Brief Title
Intrathecal Morphine in Robot-assisted Prostatectomy
Acronym
RoboITMProst
Official Title
The Efficacy of Intrathecal Morphine in Patients Undergoing Robot-assisted Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic Neoplasms, Laparoscopy, Injections, Spinal, Morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The ITM group
Arm Type
Experimental
Arm Description
The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.
Arm Title
The IV-PCA group
Arm Type
Placebo Comparator
Arm Description
The postoperative pain management includes only the intravenous patient-controlled analgesia.
Intervention Type
Drug
Intervention Name(s)
The intravenous patient-controlled analgesia
Intervention Description
The intravenous injection of morphine using the patient-controlled analgesia machine
Intervention Type
Drug
Intervention Name(s)
The intrathecal morphine injection
Intervention Description
A single injection of morphine intrathecally
Primary Outcome Measure Information:
Title
The evaluation of pain at 24 hours after surgery
Description
The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.
Time Frame
at postoperatively 24 hours
Secondary Outcome Measure Information:
Title
The consumption of analgesics
Description
The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.
Time Frame
at postoperatively 24 hours
Title
The consumption of intraoperative opioids
Description
The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.
Time Frame
From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours
Title
The side effects of opioids after surgery
Description
Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded.
Time Frame
During 72 hours after the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deok-Man Hong, PhD
Organizational Affiliation
Seoul National University of Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University of Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Intrathecal Morphine in Robot-assisted Prostatectomy

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