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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444897
• Other study ID #: 2012-12-514
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2015
• Last updated: May 14, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Epidural 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
• IV 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.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	pain degree was checked at every 24hours for 5days after operation	24 hours after operation	No
Secondary	number of participants with complication	PCA related complication	for 5days after operation	No
Secondary	Bowel motility	by counting Colomark on abdomen x-ray	for 5days after operation	No