Intrathecal Morphine in Robot-assisted Prostatectomy

N/ACompletedNCT01991275

Seoul National University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

The intravenous patient-controlled analgesiaDRUG

The intravenous injection of morphine using the patient-controlled analgesia machine

The intrathecal morphine injectionDRUG

A single injection of morphine intrathecally

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University of Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: at postoperatively 24 hours

Secondary Outcomes

The consumption of analgesics

The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.

Time frame: at postoperatively 24 hours

The consumption of intraoperative opioids

The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.

Time frame: 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.

Time frame: During 72 hours after the end of surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.