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NCT Number: NCT01997788

The Intrathecal Morphine for Nephrectomy

To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Agnosia Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 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

The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.

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 intrathecal morphine injection

Drug

A single injection of morphine intrathecally

The intravenous patient-controlled analgesia

Drug

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

Demerol on demand

Drug

Demerol 25 mg intravenously when pain scores more than 5.

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 Open Nephrectomy

Acronym: EMPON

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 28, 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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