Intrathecal Morphine in Robot-assisted Prostatectomy

NCT ID: NCT01991275

Last Updated: 2015-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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The ITM group

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

Group Type EXPERIMENTAL

The intravenous patient-controlled analgesia

Intervention Type DRUG

The intravenous injection of morphine using the patient-controlled analgesia machine

The intrathecal morphine injection

Intervention Type DRUG

A single injection of morphine intrathecally

The IV-PCA group

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

Group Type PLACEBO_COMPARATOR

The intravenous patient-controlled analgesia

Intervention Type DRUG

The intravenous injection of morphine using the patient-controlled analgesia machine

Interventions

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The intravenous patient-controlled analgesia

The intravenous injection of morphine using the patient-controlled analgesia machine

Intervention Type DRUG

The intrathecal morphine injection

A single injection of morphine intrathecally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Deok Man Hong

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deok-Man Hong, PhD

Role: STUDY_DIRECTOR

Seoul National University of Hospital

Locations

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Seoul National University of Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ITMRoboProstDMHong

Identifier Type: -

Identifier Source: org_study_id

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