Prostatic Neoplasms
Conditions
Keywords
Prostatic Neoplasms, Laparoscopy, Injections, Spinal, Morphine
Brief summary
This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy
Detailed description
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.
Interventions
The intravenous injection of morphine using the patient-controlled analgesia machine
A single injection of morphine intrathecally
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The evaluation of pain at 24 hours after surgery | at postoperatively 24 hours | The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The consumption of analgesics | at postoperatively 24 hours | The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared. |
| The consumption of intraoperative opioids | From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours | The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared. |
| The side effects of opioids after surgery | During 72 hours after the end of surgery | Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded. |
Countries
South Korea
Outcome results
None listed