The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy

Keimyung University Dongsan Medical Center60 enrolled

Overview

This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

Epidural PCA RopivacaineDRUG

Epidural catheter insertion at T10 level before surgery, the tip of catheter location at T8-9 level. Total volume: 500ml, 16.7mcg/kg+0.75% Ropivacaine 80ml+N/S

IV PCA Fentanyl+nefopam+RamosetronDRUG

Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed adenocarcinoma in stomach * Males or Females, aged≥19 years and ≤80 years * Scheduled as laparoscopic gastrectomy * Patient has given their written informed consent to participate in the study Exclusion Criteria: * History of hypersensitivity for analgesics * Recent history of narcotic analgesics * Disability of central nerve system * Uncontrolled co-morbidity

Locations (1)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Outcomes

Primary Outcomes

VAS score

pain degree was checked at every 24hours for 5days after operation

Time frame: 24 hours after operation

Secondary Outcomes

number of participants with complication

PCA related complication

Time frame: for 5days after operation

Bowel motility

by counting Colomark on abdomen x-ray

Time frame: for 5days after operation

Data from ClinicalTrials.gov

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