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-

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Gastric Cancer

Treatments: Drug: morphine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01234272

4-2010-0368

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

ITM-IVPCA

Experimental group

Description:

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

Treatment:

Drug: morphine

PCEA

Active Comparator group

Description:

PCEA:epidural PCA(patient controlled analgesia)

Treatment:

Drug: Ropivacaine