The Intrathecal Morphine for Nephrectomy

N/ACompletedNCT01997788

Seoul National University Hospital46 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Renal Cell Carcinoma

Interventions

The intrathecal morphine injectionDRUG

A single injection of morphine intrathecally

The intravenous patient-controlled analgesiaDRUG

The intravenous injection of morphine using the patient-controlled analgesia machine

Demerol on demandDRUG

Demerol 25 mg intravenously when pain scores more than 5.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

Seoul National University of Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: at postoperatively 24 hours

Secondary Outcomes

The consumption of analgesics

The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.

Time frame: at postoperatively 24 hours

The consumption of intraoperative opioids

The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.

Time frame: From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours

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.

Time frame: During 72 hours after the end of surgery

Data from ClinicalTrials.gov

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