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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epidural Analgesia, Postoperative Pain

Intervention / Treatment
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* Drug: Current practice
* Drug: Protocol based


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Current practice<br>Epidural insertion and epidural drug administration depend on anesthetist in charge | Drug: Current practice<br>* Epidural insertion and epidural drug administration depend on anesthetist in charge<br>|
| Experimental: Protocol based<br>Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based | Drug: Protocol based<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Analgesia, Postoperative Pain