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

Epidural Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301932
• Other study ID #: ANE-2562-06771
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidural Analgesia
• Patient Controlled Analgesia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative opioid consumption	Post-operative opioid consumption at 24,48,72 hour	Within 72 hours