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

Primary Purpose

Epidural Analgesia, Postoperative Pain

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Current practice
Protocol based
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epidural Analgesia focused on measuring Epidural Analgesia, Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Siriraj hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Current practice

Protocol based

Arm Description

Epidural insertion and epidural drug administration depend on anesthetist in charge

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

Outcomes

Primary Outcome Measures

Overall incidence of inadequate epidural analgesia
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

Side effects
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

Full Information

First Posted
September 29, 2019
Last Updated
July 22, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04111406
Brief Title
Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
Official Title
Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
covid19 situation
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural Analgesia, Postoperative Pain
Keywords
Epidural Analgesia, Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current practice
Arm Type
Other
Arm Description
Epidural insertion and epidural drug administration depend on anesthetist in charge
Arm Title
Protocol based
Arm Type
Experimental
Arm Description
Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based
Intervention Type
Drug
Intervention Name(s)
Current practice
Intervention Description
Epidural insertion and epidural drug administration depend on anesthetist in charge
Intervention Type
Drug
Intervention Name(s)
Protocol based
Intervention Description
Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based insertion at mid-level of surgical insertion insertion depth is 3-5 cm in space, not more than 5 cm using benzoin tincture and transparent dressing to fix catheter test dose with 2%xylocaine with adrenaline 1:200,000 3ml If not cover desired dermatome: 2% lidocaine with adr added 3 ml every 5 min (up to 2 times) After induction and patients' hemodynamic are stable. Load 2 mg morphine with 0.0625% bupivacaine + morphine 0.02 mg/ml 3 ml then continuous infusion with rate according to initial local anesthetic requirement for incisional area coverage
Primary Outcome Measure Information:
Title
Overall incidence of inadequate epidural analgesia
Description
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.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Side effects
Description
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
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawinee Pangthipampai, M.D.
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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

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