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CompletedNCT01991275RoboITMProstUpdated Jul 3, 2015

Intrathecal Morphine in Robot-assisted Prostatectomy

An interventional study of The intravenous patient-controlled analgesia and The intrathecal morphine injection in Prostatic Neoplasms, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-03.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prostatic Neoplasms

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Keywords

  • Prostatic Neoplasms
  • Laparoscopy
  • Injections, Spinal
  • Morphine
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 30 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for the open nephrectomy

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    The ITM group

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

    Drug: The intravenous patient-controlled analgesia · Drug: The intrathecal morphine injection

  • Placebo comparator
    The IV-PCA group

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

    Drug: The intravenous patient-controlled analgesia

Interventions

  • DrugThe intravenous patient-controlled analgesia

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

  • DrugThe intrathecal morphine injection

    A single injection of morphine intrathecally

06

What researchers measure

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.

    Time frame: at postoperatively 24 hours

Secondary outcomes

  1. The consumption of analgesics

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

    Time frame: at postoperatively 24 hours

  2. The consumption of intraoperative opioids

    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

  3. 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.

    Time frame: During 72 hours after the end of surgery

07

Study locations

1 site
  • Seoul National University of Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01991275
Lead sponsor
Seoul National University Hospital
Responsible party
Deok Man Hong (Associate professor, Seoul National University Hospital) — Principal investigator
First posted
Nov 25, 2013
Start date
Nov 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jul 3, 2015

Study contacts

Deok-Man Hong, PhD
study director · Seoul National University of Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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