NCT01991275

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

November 18, 2013

Last Update Submit

July 1, 2015

Conditions

Prostatic Neoplasms

Keywords

Prostatic NeoplasmsLaparoscopyInjections, SpinalMorphine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • The consumption of analgesics

    at postoperatively 24 hours

  • The consumption of intraoperative opioids

    From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours

  • The side effects of opioids after surgery

    During 72 hours after the end of surgery

Study Arms (2)

The ITM group

EXPERIMENTAL

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

Drug: The intravenous patient-controlled analgesiaDrug: The intrathecal morphine injection

The IV-PCA group

PLACEBO COMPARATOR

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

Drug: The intravenous patient-controlled analgesia

Interventions

The intravenous patient-controlled analgesiaDRUG

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

The ITM groupThe IV-PCA group
The intrathecal morphine injectionDRUG

A single injection of morphine intrathecally

The ITM group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for the open nephrectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University of Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Deok-Man Hong, PhD

    Seoul National University of Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations

KR(1)