Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery

Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery in Siriraj Hospital

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.

Study Overview

• Status: Completed
• Conditions: Analgesia Disorder; Adverse Reaction to Epidural Anesthesia; Anesthetic Complication Epidural
• Intervention / Treatment: Procedure: Elective Thoracic and Abdominal Surgery Patients

Detailed Description

Epidural analgesia is the recommended perioperative analgesia in patients having major surgery in order to significantly reduced pain scores, minimize patient distress and can accelerate postoperative recovery especially with the major operation This technique has been reported to provide better pain control and less postoperative fatigue compared with patients receiving general anesthesia alone.Additionally, it is recommended in patients having major surgery to allow patients to mobilize quickly and have effective mobilization.This technique has been shown to be highly efficient at preventing postoperative ileus and various complications. Moreover, epidural analgesic technique is demonstrated to be safer and have fewer side effects than using intravenous opioids alone.

However, the epidural technique is not universally successful and the number of patients experiencing inadequate analgesia with this technique is approximately 12-32%. The failure of epidural analgesia is still a frequent clinical problem and needs active management including a new block or other analgesic medication in order to rescue postoperative pain. Previous study showed that the incidence of patients having epidural analgesia with postoperative moderate pain was 20.9% and that with severe pain was 7.8%. In Siriraj Hospital, recent study showed that 19.6% of patients having elective upper abdominal surgery under general anesthesia combined with epidural analgesia reported severe first pain scores in post anesthetic care unit.27 As a result of severe pain, patients needed a number of intervention and management from acute pain service, and finally spent longer time in post anesthetic care unit.

Inadequate pain control in patients receiving epidural analgesia frequently occurred in clinical practice but the number of the success rate or the failure rate have not been reported in our hospital. 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.

• Study Type: Observational
• Enrollment (Actual): 364

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

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Requiring Rescue Analgesic Medication	Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation	during the period of retaining of epidural catheter up to 3 days after operation
Duration Retaining Epidural Catheter	Duration retaining epidural catheter in hospital	the period of retaining of epidural catheter up to 3 days after operation
All Adverse Effects and Postoperative Complications.	All Adverse Effects and Postoperative Complications included the number of patients having postoperative nausea and vomiting; hypotension; accidental dural puncture and post-dural puncture headache.	the period of retaining of epidural catheter up to 3 days after operation

Collaborators and Investigators

• Sponsor: Siriraj Hospital
• Investigators: Principal Investigator: Mingkwan Wongyingsinn, MD, MSc, Siriraj Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Epidural analgesia; Pain score
• Other Study ID Numbers: SIRB004

Plan for Individual participant data (IPD)

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