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Completed

NCT Number: NCT01991275

Intrathecal Morphine in 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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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University of Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The intravenous patient-controlled analgesia

Drug

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

The intrathecal morphine injection

Drug

A single injection of morphine intrathecally

Primary outcomes

  1. 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

  1. The consumption of analgesics

    Time frame: at postoperatively 24 hours

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

  2. The consumption of intraoperative opioids

    Time frame: 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.

  3. The side effects of opioids after surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Efficacy of Intrathecal Morphine in Patients Undergoing Robot-assisted Prostatectomy

Acronym: RoboITMProst

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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