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The Intrathecal Morphine for Nephrectomy (EMPON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997788
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Deok Man Hong, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE September 10, 2013
First Posted Date  ICMJE November 28, 2013
Last Update Posted Date July 3, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2013)
  • The consumption of analgesics [ Time Frame: at postoperatively 24 hours ]
    The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.
  • The consumption of intraoperative opioids [ Time Frame: From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours ]
    The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.
  • The side effects of opioids after surgery [ Time Frame: During 72 hours after the end of surgery ]
    Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Intrathecal Morphine for Nephrectomy
Official Title  ICMJE The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy
Brief Summary To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.
Detailed Description The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: The intrathecal morphine injection
    A single injection of morphine intrathecally
  • Drug: The intravenous patient-controlled analgesia
    The intravenous injection of morphine using the patient-controlled analgesia machine
  • Drug: Demerol on demand
    Demerol 25 mg intravenously when pain scores more than 5.
Study Arms  ICMJE
  • Experimental: The ITM group
    The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
    Interventions:
    • Drug: The intrathecal morphine injection
    • Drug: The intravenous patient-controlled analgesia
    • Drug: Demerol on demand
  • Placebo Comparator: The IV-PCA group
    The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
    Interventions:
    • Drug: The intravenous patient-controlled analgesia
    • Drug: Demerol on demand
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2015)
46
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2013)
23
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01997788
Other Study ID Numbers  ICMJE ITMPKidney
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deok Man Hong, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Deok-Man Hong, PhD Seoul National University of Hospital
PRS Account Seoul National University Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP