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The Intrathecal Morphine for Nephrectomy (EMPON)

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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

Brief Summary:
To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: The intrathecal morphine injection Drug: The intravenous patient-controlled analgesia Drug: Demerol on demand Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy
Study Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013


Arm Intervention/treatment
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.
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.

Placebo Comparator: The IV-PCA group
The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997788


Locations
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Korea, Republic of
Seoul National University of Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Deok-Man Hong, PhD Seoul National University of Hospital
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Responsible Party: Deok Man Hong, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01997788    
Other Study ID Numbers: ITMPKidney
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Keywords provided by Deok Man Hong, Seoul National University Hospital:
Injection, Spinal
Morphine
Analgesia
Patient-Controlled
Pain
Postoperative
Combined Modality Therapy
Nephrectomy
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents