The Intrathecal Morphine for Nephrectomy

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: The intrathecal morphine injection
* Drug: The intravenous patient-controlled analgesia
* Drug: Demerol on demand


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The ITM group<br>The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. | Drug: The intrathecal morphine injection<br>* A single injection of morphine intrathecally<br>Drug: The intravenous patient-controlled analgesia<br>* The intravenous injection of morphine using the patient-controlled analgesia machine<br>Drug: Demerol on demand<br>* Demerol 25 mg intravenously when pain scores more than 5.<br>|
| Placebo Comparator: The IV-PCA group<br>The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. | Drug: The intravenous patient-controlled analgesia<br>* The intravenous injection of morphine using the patient-controlled analgesia machine<br>Drug: Demerol on demand<br>* Demerol 25 mg intravenously when pain scores more than 5.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injection, Spinal, Morphine, Analgesia, Patient-Controlled, Postoperative, Combined Modality Therapy, Nephrectomy, Pain