Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111406
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Epidural Analgesia Postoperative Pain Drug: Current practice Drug: Protocol based Not Applicable

Detailed Description:
Our hospital is a big tertiary hospital and has many staffs. The 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, we believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

  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




Primary Outcome Measures :
  1. Overall incidence of inadequate epidural analgesia [ Time Frame: 72 hours ]
    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 :
  1. Side effects [ Time Frame: 72 hours ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111406


Contacts
Layout table for location contacts
Contact: Pawinee Pangthipampai, M.D. +6686 400 1721 pawinee141@gmail.com

Locations
Layout table for location information
Thailand
Siriraj hospital Recruiting
Bangkok, Thailand, 10700
Contact: Pawinee Pangthipampai, M.D.    66864001721    pawinee141@gmail.com   
Principal Investigator: Pawinee Pangthipampai, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Principal Investigator: Pawinee Pangthipampai, M.D. Siriraj Hospital
Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04111406    
Other Study ID Numbers: Si 342/2018
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Epidural Analgesia
Postoperative Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Pain