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This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy
Prostatectomy is the treatment of choice for prostate cancer. The robot-assisted prostatectomy is becoming the most popular surgical method for prostate cancer. The small incision after robot-assisted prostatectomy is thought to reduce the postoperative pain. There is few investigations for the strategy to reduce the postoperative pain of robot-assisted prostatectomy.
The intrathecal morphine injection is known to reduce postoperative pain for surgeries like hepatectomy, myomectomy and open prostatectomy. This method, however, is not yet studied for the robot-assisted prostatectomy. This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy.
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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. |
|
| The IV-PCA group | Placebo Comparator | The postoperative pain management includes only the intravenous patient-controlled analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The intravenous patient-controlled analgesia | Drug | The intravenous injection of morphine using the patient-controlled analgesia machine |
|
| 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 |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| The intrathecal morphine injection | Drug | A single injection of morphine intrathecally |
|
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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |