The Intrathecal Morphine for Nephrectomy

Not Applicable

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: The intrathecal morphine injection; Drug: The intravenous patient-controlled analgesia; Drug: Demerol on demand

• Registration Number: NCT01997788
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted QC: 2013-11-24
• Study First Posted: 2013-11-28
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Patients scheduled for the open nephrectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The ITM group	The intravenous patient-controlled analgesia	The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
The ITM group	Demerol on demand	The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
The IV-PCA group	The intravenous patient-controlled analgesia	The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
The ITM group	The intrathecal morphine injection	The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
The IV-PCA group	Demerol on demand	The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.

Primary Outcome Measures

Name	Time	Method
The evaluation of pain at 24 hours after surgery	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

Name	Time	Method
The consumption of analgesics	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	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	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.

Trial Locations

Locations (1)

Seoul National University of Hospital; 🇰🇷 Seoul, Korea, Republic of