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NCT Number: NCT04079673

Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota

As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.

The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.

Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.

Exclusion criteria

  • Previous use of antibiotics within four weeks.
  • Previous gastrointestinal surgery.

Treatment and study plan

Patient controlled epidural analgesia

Procedure

Patient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control

Other names: PCEA

Intravenous patient controlled analgesia

Drug

Intravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control

Other names: IVPCA

Primary outcomes

  1. Microbiota analysis

    Time frame: one month

    16S metagenomic sequence processing

Secondary outcomes

  1. LPS-binding protein

    Time frame: one month

    LPS-binding protein(mcg/mL)

  2. Intestinal fatty acid binding protein

    Time frame: one month

    Intestinal fatty acid binding protein(ng/mL)

  3. IgA

    Time frame: one month

    IgA(mcg/mL)

  4. IL-6

    Time frame: one month

    IL-6(ng/mL)

  5. I-FEED scoring

    Time frame: one week

    I-FEED scoring system for postoperative gastrointestinal function:

    • Intake(score): tolerating oral diet(0), limited tolerance(1), complete Intolerance(3)
    • Feeling nauseated(score): none(0), responsive to treatment(1), resistant to treatment(3)
    • Emesis(score): none(0), ≧1 episode of low volume(<100mL) and none bilious(1), ≧1 episode of high volume(>100mL) or bilious(3)
    • Exam(score): no distension(0), distension without tympany(1), significant distension with tympany(3)
    • Duration of symptoms(score):0-24hours(0),24-72hours(1),>72hours(2)

    Total score: 0-2 normal, 3-5 postoperative GI intolerance, >6 postoperative GI dysfunction

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Effect of Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota and Gastrointestinal Function Recovery in Living Donor Hepatectomy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
May 8, 2026

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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