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-

NCT01234272 | Completed Phase 4

• 1 other identifier: 4-2010-0368
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

patients with; undergoing; gastrectomy

Study Arms (2)

ITM-IVPCA

EXPERIMENTAL

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

Drug: morphine

PCEA

ACTIVE COMPARATOR

PCEA:epidural PCA(patient controlled analgesia)

Drug: Ropivacaine

Interventions

morphine DRUG

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)

ITM-IVPCA

Ropivacaine DRUG

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)

PCEA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly.
• prior history of abdominal surgery or spine surgery.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Morphine; Ropivacaine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bon-Nyeo Koo, MD, Ph.D

  Severance Hospital, Department of Anesthesia and Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

KR (1)