The Efficacy of Intrathecal Morphine in Patients Undergoing Robot-assisted Prostatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The evaluation of pain at 24 hours after surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
The ITM group
The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.
Intervention: The intravenous patient-controlled analgesia (Drug)
The ITM group
The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia.
Intervention: The intrathecal morphine injection (Drug)
The IV-PCA group
The postoperative pain management includes only the intravenous patient-controlled analgesia.
Intervention: The intravenous patient-controlled analgesia (Drug)
Outcomes
Primary Outcomes
The evaluation of pain at 24 hours after surgery
Time Frame: 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 Outcomes
- The consumption of analgesics(at postoperatively 24 hours)
- The side effects of opioids after surgery(During 72 hours after the end of surgery)
- The consumption of intraoperative opioids(From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours)
Investigators
Deok Man Hong
Associate professor
Seoul National University Hospital