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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02444897

Enrollment

Registered

2015-05-15

Start date

2013-09-30

Completion date

2014-12-31

Last updated

2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric cancer, epidural, PCA, laparoscopy

Brief summary

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.

Interventions

DRUGEpidural PCA Ropivacaine

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

DRUGIV PCA Fentanyl+nefopam+Ramosetron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
VAS score	24 hours after operation	pain degree was checked at every 24hours for 5days after operation

Secondary

Measure	Time frame	Description
number of participants with complication	for 5days after operation	PCA related complication
Bowel motility	for 5days after operation	by counting Colomark on abdomen x-ray

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026