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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04111406
• Other study ID #: Si 342/2018
• Status: Terminated
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: October 28, 2021

Study information

• Verified date: July 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidural Analgesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Current practice
Epidural insertion and epidural drug administration depend on anesthetist in charge
• Protocol based
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

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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