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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01997788
Other study ID # ITMPKidney
Secondary ID
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


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
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