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

• Sponsor: Keimyung University Dongsan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02444897
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Epidural PCA Ropivacaine; Drug: IV PCA Fentanyl+nefopam+Ramosetron	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural PCA group Epidural patient-controlled analgesia group	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; Other Names: Epidural patient-controlled analgesia Ropivacaine
Active Comparator: IV PCA group Intravenous patient-controlled analgesia	Drug: 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.; Other Names: intravenous patient-controlled analgesia

Outcome Measures

Primary Outcome Measures

1. VAS score [24 hours after operation]

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

Secondary Outcome Measures

1. number of participants with complication [for 5days after operation]

   PCA related complication

2. Bowel motility [for 5days after operation]

   by counting Colomark on abdomen x-ray

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of	700-712

Sponsors and Collaborators

• Keimyung University Dongsan Medical Center

Investigators

• Principal Investigator: Seung Wan Ryu, M.D., Ph.D., Director of gastrointestinal surgery devision, associate proffessor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung Wan Ryu, Director of Gastrointesinal surgery, associate professor, Keimyung University Dongsan Medical Center
• ClinicalTrials.gov Identifier: NCT02444897
• Other Study ID Numbers: 2012-12-514
• First Posted: May 15, 2015
• Last Update Posted: May 15, 2015
• Last Verified: May 1, 2015

• Keywords provided by Seung Wan Ryu, Director of Gastrointesinal surgery, associate professor, Keimyung University Dongsan Medical Center: Gastric cancer; epidural; PCA; laparoscopy
• Additional relevant MeSH terms: Stomach Neoplasms; Fentanyl; Nefopam; Ramosetron; Ropivacaine

Study Results

No Results Posted as of May 15, 2015