The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy

The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy: A Propensity Score Matching Analysis

This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.

The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA?

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia; Patient Controlled Analgesia
• Intervention / Treatment: Procedure: Open liver resection

Detailed Description

After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2562-06771), the investigators performed a retrospective review of all patients who underwent an elective open liver resection in the specialized hepato-biliary center from January 2007 through December 2018. This retrospective inquiry comprised 612 patients. The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected. The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, intra-operative opioid consumption and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. Post-operative pain score and opioid consumption also be collected.

• Study Type: Observational
• Enrollment (Actual): 654

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients more than 18 years old, who underwent an open hepatectomy between January 2007 - December 2018 at Maharay Nakhon Chiangmai Hospital

Description

Inclusion Criteria:

• All gender age above 18 years old
• Undergoing open liver resection surgery

Exclusion Criteria:

• No documentation of the numerical rating scale (NRS)
• Epidural failure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epidural analgesia; Group of the patients received epidural analgesia	Procedure: Open liver resection; The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology
Non epidural analgesia; Group of the patients who did not received epidural analgesia	Procedure: Open liver resection; The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative opioid consumption	Post-operative opioid consumption at 24,48,72 hour	Within 72 hours

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Liver resection; Propensity score matching
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: ANE-2562-06771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No