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Completed

NCT Number: NCT02444897

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Epidural patient-controlled analgesia Ropivacaine

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.

Other names: intravenous patient-controlled analgesia

Primary outcomes

  1. VAS score

    Time frame: 24 hours after operation

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

Secondary outcomes

  1. number of participants with complication

    Time frame: for 5days after operation

    PCA related complication

  2. Bowel motility

    Time frame: for 5days after operation

    by counting Colomark on abdomen x-ray

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2015
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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