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

NCT02444897 | Completed Phase 3

• 1 other identifier: 2012-12-514
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric cancer; epidural; PCA; laparoscopy

Outcome Measures

Primary Outcomes (1)

• VAS score

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

  24 hours after operation

Secondary Outcomes (2)

• number of participants with complication

  for 5days after operation

• Bowel motility

  for 5days after operation

Study Arms (2)

Epidural PCA group

EXPERIMENTAL

Epidural patient-controlled analgesia group

Drug: Epidural PCA Ropivacaine

IV PCA group

ACTIVE COMPARATOR

Intravenous patient-controlled analgesia

Drug: IV PCA Fentanyl+nefopam+Ramosetron

Interventions

Epidural PCA Ropivacaine DRUG

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

Also known as: Epidural patient-controlled analgesia Ropivacaine

Epidural PCA group

IV PCA Fentanyl+nefopam+Ramosetron DRUG

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

Also known as: intravenous patient-controlled analgesia

IV PCA group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of hypersensitivity for analgesics
• Recent history of narcotic analgesics
• Disability of central nerve system
• Uncontrolled co-morbidity

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Seung Wan Ryu, M.D., Ph.D.

  Director of gastrointestinal surgery devision, associate proffessor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastrointesinal surgery, associate professor

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: May 15, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

KR (1)