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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The ITM group | Experimental | The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. |
|
| The IV-PCA group | Placebo Comparator | The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The intrathecal morphine injection | Drug | A single injection of morphine intrathecally |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deok-Man Hong, PhD | Seoul National University of Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University of Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| The intravenous patient-controlled analgesia |
| Drug |
The intravenous injection of morphine using the patient-controlled analgesia machine |
|
| Demerol on demand | Drug | Demerol 25 mg intravenously when pain scores more than 5. |
|
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 |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |