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.
Information provided by:
Yonsei University Identifier:
First received: November 3, 2010
Last updated: August 15, 2011
Last verified: August 2011
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:

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)


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01234272

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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 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

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 08, 2016