The Intrathecal Morphine for Nephrectomy (EMPON)

The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy

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

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Drug: The intrathecal morphine injection; Drug: The intravenous patient-controlled analgesia; Drug: Demerol on demand

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University of Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The ITM group; The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.	Drug: The intrathecal morphine injection; A single injection of morphine intrathecally; Drug: The intravenous patient-controlled analgesia; The intravenous injection of morphine using the patient-controlled analgesia machine; Drug: Demerol on demand; Demerol 25 mg intravenously when pain scores more than 5.
Placebo Comparator: The IV-PCA group; The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.	Drug: The intravenous patient-controlled analgesia; The intravenous injection of morphine using the patient-controlled analgesia machine; Drug: Demerol on demand; Demerol 25 mg intravenously when pain scores more than 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at postoperatively 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The consumption of analgesics	The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.	at postoperatively 24 hours
The consumption of intraoperative opioids	The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.	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.	During 72 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: November 24, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Morphine; Nephrectomy; Postoperative; Combined Modality Therapy; Injection, Spinal; Patient-Controlled
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: ITMPKidney