The Intrathecal Morphine for Nephrectomy

NCT01997788 | Completed DMC

• 1 other identifier: ITMPKidney
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Cell Carcinoma

Keywords

Injection, Spinal; Morphine; Analgesia; Patient-Controlled; Pain; Postoperative; Combined Modality Therapy; Nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The consumption of analgesics

  at postoperatively 24 hours

• The consumption of intraoperative opioids

  From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours

• The side effects of opioids after surgery

  During 72 hours after the end of surgery

Study Arms (2)

The ITM group

EXPERIMENTAL

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; Drug: The intravenous patient-controlled analgesia; Drug: Demerol on demand

The IV-PCA group

PLACEBO COMPARATOR

The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.

Drug: The intravenous patient-controlled analgesia; Drug: Demerol on demand

Interventions

The intrathecal morphine injection DRUG

A single injection of morphine intrathecally

The ITM group

The intravenous patient-controlled analgesia DRUG

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

The ITM group; The IV-PCA group

Demerol on demand DRUG

Demerol 25 mg intravenously when pain scores more than 5.

The ITM group; The IV-PCA group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for the open nephrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University of Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Agnosia; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Deok-Man Hong, PhD

  Seoul National University of Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: November 28, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

KR (1)