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Clinical Trials/NCT01991275
NCT01991275
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country30 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
The intravenous patient-controlled analgesia
Conditions
Prostatic Neoplasms
Sponsor
Seoul National University Hospital
Enrollment
30
Locations
1
Primary Endpoint
The evaluation of pain at 24 hours after surgery
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deok Man Hong

Associate professor

Seoul National University Hospital

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

Arms & Interventions

The ITM group

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

Intervention: The intravenous patient-controlled analgesia

The ITM group

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

Intervention: The intrathecal morphine injection

The IV-PCA group

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

Intervention: The intravenous patient-controlled analgesia

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The consumption of analgesics(at postoperatively 24 hours)
  • The side effects of opioids after surgery(During 72 hours after the end of surgery)
  • The consumption of intraoperative opioids(From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours)

Study Sites (1)

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