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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 analgesics

The 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

Page last updated: August 23, 2015

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