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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Epidural Analgesia
• Intervention / Treatment: Drug: Current practice; Drug: Protocol based

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Pawinee Pangthipampai, M.D., Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 29, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Pain; Epidural Analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Si 342/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No