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Completed

NCT Number: NCT02458573

Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 150-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
  • gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion criteria

  • ASA physical status Ⅳ
  • bradycardia (< 60 bpm), arrhythmia
  • uncompensated heart failure
  • hepatic failure (Child-Pugh score B)
  • renal failure (eGFR MDRD < 60 ml/min/1.73m2)

Treatment and study plan

continuous epidural analgesia

Other

the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.

continuous intravenous analgesia

Other

the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.

Primary outcomes

  1. the time to first gas passing after surgery

    Time frame: within 5days after surgery

    Outcome will be assessed by a investigator blinded to the study group.

  2. the time to resume water intake after surgery

    Time frame: within 5days after surgery

    Outcome will be assessed by a investigator blinded to the study group.

  3. soft diet intake after surgery

    Time frame: within 5days after surgery

    Outcome will be assessed by a investigator blinded to the study group.

Secondary outcomes

  1. postoperative pain

    Time frame: immediately after surgery to 48 hours

    numerical rating scale 0 (no pain) to 10 (worst pain)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Jan 25, 2017

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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