The Intrathecal Morphine for Nephrectomy
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Cell Carcinoma
Intervention: The intrathecal morphine injection (Drug); The intravenous patient-controlled analgesia (Drug); Demerol on demand (Drug)
Phase: N/A
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Deok-Man Hong, PhD, Study Director, Affiliation: Seoul National University of Hospital
Summary
To evaluate the efficacy and the safety of the intrathecal morphine injection in the open
nephrectomy.
Clinical Details
Official title: The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The evaluation of pain at 24 hours after surgery
Secondary outcome: The consumption of analgesicsThe consumption of intraoperative opioids The side effects of opioids after surgery
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Seoul National University of Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: August 2013
Last updated: July 1, 2015
|