Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice

Not Applicable

Terminated

• Conditions: Epidural Analgesia; Postoperative Pain
• Interventions: Drug: Current practice; Drug: Protocol based

• Registration Number: NCT04111406
• Lead Sponsor: Mahidol University

Brief Summary

Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.

Detailed Description

A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-09
• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-09-29
• Study First Posted: 2019-10-01
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.

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Exclusion Criteria

• Coagulopathy
• Allergy to study drugs: local anesthetics and opioids
• History of chronic pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Current practice	Current practice	Epidural insertion and epidural drug administration depend on anesthetist in charge
Protocol based	Protocol based	Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based

Primary Outcome Measures

Name	Time	Method
Overall incidence of inadequate epidural analgesia	72 hours	To compare the overall incidence of inadequate epidural analgesia until considered removal between protocol-based and current practice by using the definition of inadequate analgesia as pain score of 4 or more out of 10 on numeric rating scale (0; no pain, 10; worst imaginable pain) at rest.

Secondary Outcome Measures

Name	Time	Method
Side effects	72 hours	To compare the incidence of undesirable side effects of epidural catheter between groups: sedation, respiratory depression, hypotension, motor weakness, postoperative nausea and vomiting and pruritus

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand