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Clinical Trials/NCT04111406
NCT04111406
Terminated
Not Applicable

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

Mahidol University1 site in 1 country29 target enrollmentJanuary 9, 2019

Overview

Phase
Not Applicable
Intervention
Current practice
Conditions
Epidural Analgesia
Sponsor
Mahidol University
Enrollment
29
Locations
1
Primary Endpoint
Overall incidence of inadequate epidural analgesia
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2019
End Date
October 28, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Current practice

Epidural insertion and epidural drug administration depend on anesthetist in charge

Intervention: Current practice

Protocol based

Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based

Intervention: Protocol based

Outcomes

Primary Outcomes

Overall incidence of inadequate epidural analgesia

Time Frame: 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 Outcomes

  • Side effects(72 hours)

Study Sites (1)

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