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

K

Keimyung University

Status and phase

Completed
Phase 3

Conditions

Gastric Cancer

Treatments

Drug: IV PCA Fentanyl+nefopam+Ramosetron
Drug: Epidural PCA Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02444897
2012-12-514

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Epidural PCA group
Experimental group
Description:
Epidural patient-controlled analgesia group
Treatment:
Drug: Epidural PCA Ropivacaine
IV PCA group
Active Comparator group
Description:
Intravenous patient-controlled analgesia
Treatment:
Drug: IV PCA Fentanyl+nefopam+Ramosetron

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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