NCT02315261

Brief Summary

This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 13, 2018

Completed
Last Updated

November 13, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

December 4, 2014

Results QC Date

April 5, 2017

Last Update Submit

April 16, 2018

Conditions

Analgesia DisorderAnesthetic Complication EpiduralAdverse Reaction to Epidural Anesthesia

Keywords

Epidural analgesiaPain score

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7

    Verbal Rating Scale Pain will routinely be assessed at postoperative 24 hours by the ward nurse. Minimum and maximum scores possible are 0 and 10. The higher values represent patients having more pain. Severe pain is defined as Verbal Rating Scale pain at rest more than 7.

    at postoperative 24 hours

Secondary Outcomes (3)

  • Number of Patients Requiring Rescue Analgesic Medication

    during the period of retaining of epidural catheter up to 3 days after operation

  • Duration Retaining Epidural Catheter

    the period of retaining of epidural catheter up to 3 days after operation

  • All Adverse Effects and Postoperative Complications.

    the period of retaining of epidural catheter up to 3 days after operation

Interventions

Elective Thoracic and Abdominal Surgery PatientsPROCEDURE

This is an observational audit, reviewing the implementation of a standard care practice and requiring de-identified data collection in Elective Thoracic and Abdominal Surgery Patients only. All collected data will be that which is routinely part of normal clinical practice. The Research staff will systematically collect data on each patient. Some information can be obtained from the medical record, intraoperative anesthetic record, acute pain service record, etc whereas other information has to be obtained from direct observation at the bedside.

Also known as: Epidural Analgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital

You may qualify if:

  • patients aged more than 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital

You may not qualify if:

  • inability to communicate or inform pain score
  • cesarean section or labor analgesia
  • additional analgesic techniques (spinal analgesia, paravertebral nerve block, intercostal block, transversus abdominis plane block, rectus sheath block, ilioinguinal block, iliohypogastric block
  • emergency surgery
  • fail epidural block after test dose of local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Wongyingsinn M, Anuwongjaroen A. Effectiveness of Postoperative Epidural Analgesia for Thoracic and Abdominal Surgery in Siriraj Hospital. J Med Assoc Thai. 2016 May;99(5):531-8.

    PMID: 27501608DERIVED

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Results Point of Contact

Title
Dr.Mingkwan Wongyingsinn
Organization
Faculty of Medicine Siriraj Hospital
minkcheerful@hotmail.com
66824197995

Study Officials

  • Mingkwan Wongyingsinn, MD, MSc

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Doctor

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 11, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

November 13, 2018

Results First Posted

November 13, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)