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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:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01234272
First received: November 3, 2010
Last updated: August 15, 2011
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 3, 2010
Last Updated: August 15, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Analgesics
Fentanyl
Morphine
Ropivacaine
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Anesthetics, Local

ClinicalTrials.gov processed this record on May 22, 2013