The Intrathecal Morphine for Nephrectomy (EMPON)

Seoul National University

Status

Completed

Conditions

Renal Cell Carcinoma

Treatments

Drug: The intrathecal morphine injection

Drug: Demerol on demand

Drug: The intravenous patient-controlled analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT01997788

ITMPKidney

Details and patient eligibility

About

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

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups, including a placebo group

The ITM group

Experimental group

Description:

The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.

Treatment:

Drug: Demerol on demand

Drug: The intrathecal morphine injection

Drug: The intravenous patient-controlled analgesia

The IV-PCA group

Placebo Comparator group

Description:

The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.

Treatment:

Drug: Demerol on demand

Drug: The intravenous patient-controlled analgesia