Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota

Not Applicable

• Conditions: Living Donor Hepatectomy
• Interventions: Procedure: Patient controlled epidural analgesia; Drug: Intravenous patient controlled analgesia

• Registration Number: NCT04079673
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2019-10-19
• Status Verified: 2020-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

1. Previous use of antibiotics within four weeks.
2. Previous gastrointestinal surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient controlled epidural analgesia	Patient controlled epidural analgesia	Use of patient controlled epidural analgesia (PCEA) for postoperative pain control
Intravenous patient controlled analgesia	Intravenous patient controlled analgesia	Use of intravenous patient controlled analgesia(IVPCA) for postoperative pain control

Primary Outcome Measures

Name	Time	Method
Microbiota analysis	one month	16S metagenomic sequence processing

Secondary Outcome Measures

Name	Time	Method
Intestinal fatty acid binding protein	one month	Intestinal fatty acid binding protein(ng/mL)
I-FEED scoring	one week	I-FEED scoring system for postoperative gastrointestinal function: 1. Intake(score): tolerating oral diet(0), limited tolerance(1), complete Intolerance(3); 2. Feeling nauseated(score): none(0), responsive to treatment(1), resistant to treatment(3); 3. Emesis(score): none(0), ≧1 episode of low volume(\<100mL) and none bilious(1), ≧1 episode of high volume(\>100mL) or bilious(3); 4. Exam(score): no distension(0), distension without tympany(1), significant distension with tympany(3); 5. 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
IL-6	one month	IL-6(ng/mL)
LPS-binding protein	one month	LPS-binding protein(mcg/mL)
IgA	one month	IgA(mcg/mL)

Trial Locations

Locations (1)

Department of Anesthesiology, National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan