The Intrathecal Morphine for Nephrectomy

Renal Cell Carcinoma Clinical Trial

— EMPON  

Official title:

The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997788
• Other study ID #: ITMPKidney
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: July 1, 2015
• Start date: August 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• The intrathecal morphine injection
A single injection of morphine intrathecally
• The intravenous patient-controlled analgesia
The intravenous injection of morphine using the patient-controlled analgesia machine
• Demerol on demand
Demerol 25 mg intravenously when pain scores more than 5.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of pain at 24 hours after surgery	The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.	at postoperatively 24 hours	No
Secondary	The consumption of analgesics	The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.	at postoperatively 24 hours	No
Secondary	The consumption of intraoperative opioids	The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.	From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours	No
Secondary	The side effects of opioids after surgery	Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded.	During 72 hours after the end of surgery	Yes