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Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234272
First Posted: November 4, 2010
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.

Condition Intervention Phase
Gastric Cancer Drug: morphine Drug: Ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Enrollment: 59
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITM-IVPCA
ITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia
Drug: morphine
ITM-IVPCA: intrathecal administration of 0.3 mg morphine before induction of general anesthesia and application of IVPCA (basal infusion: fentanyl 0.4mcg/kg/hr, bolus: 0.16mcg/kg of fentanyl with a lock out time of 15 min)
Active Comparator: PCEA
PCEA:epidural PCA(patient controlled analgesia)
Drug: Ropivacaine
PCEA: epidural administration of 5ml 0.2% ropivacaine before induction of general anesthesia and application of PCEA (basal infusion: 5ml 0.2% ropivacaine with fentanyl 0.4 mcg/kg/hr, bolus: 2ml 0.2% ropivacaine with fentanyl 0.16mcg/kg with a lockout time 15min)

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • I or II of preoperative physical status classification by the American Society of Anesthesiologists.
  • more than 20 years old.
  • undergoing gastrectomy due to gastric cancer.

Exclusion Criteria:

  • contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly.
  • prior history of abdominal surgery or spine surgery.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234272


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Bon-Nyeo Koo, MD, Ph.D Severance Hospital, Department of Anesthesia and Pain Medicine
  More Information

Responsible Party: Bon-Nyeo Koo / Associate Professor, Severance Hospital, Department of Anesthesiology & Pain Medicine
ClinicalTrials.gov Identifier: NCT01234272     History of Changes
Other Study ID Numbers: 4-2010-0368
First Submitted: November 3, 2010
First Posted: November 4, 2010
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by Yonsei University:
patients with
undergoing
gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Morphine
Fentanyl
Analgesics
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local