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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04111406
Enrollment
29
Registered
2019-10-01
Start date
2019-01-09
Completion date
2021-10-28
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Analgesia, Postoperative Pain

Keywords

Epidural Analgesia, Postoperative Pain

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.

Interventions

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 1. insertion at mid-level of surgical insertion 2. insertion depth is 3-5 cm in space, not more than 5 cm 3. using benzoin tincture and transparent dressing to fix catheter 4. 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) 5. 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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Overall incidence of inadequate epidural analgesia72 hoursTo 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

MeasureTime frameDescription
Side effects72 hoursTo compare the incidence of undesirable side effects of epidural catheter between groups: sedation, respiratory depression, hypotension, motor weakness, postoperative nausea and vomiting and pruritus

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026