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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-

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
morphine
Ropivacaine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring patients with, undergoing, gastrectomy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ITM-IVPCA

PCEA

Arm Description

ITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia

PCEA:epidural PCA(patient controlled analgesia)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 2010
Last Updated
August 15, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01234272
Brief 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-
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-
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
patients with, undergoing, gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITM-IVPCA
Arm Type
Experimental
Arm Description
ITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia
Arm Title
PCEA
Arm Type
Active Comparator
Arm Description
PCEA:epidural PCA(patient controlled analgesia)
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon-Nyeo Koo, MD, Ph.D
Organizational Affiliation
Severance Hospital, Department of Anesthesia and Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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-

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