Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery

• ClinicalTrials.gov Identifier: NCT02315261
• Recruitment Status: Completed
• First Posted: December 11, 2014
• Results First Posted: November 13, 2018
• Last Update Posted: November 13, 2018
• Sponsor: Siriraj Hospital
• Information provided by (Responsible Party): Mingkwan Wongyingsinn, MD, Siriraj Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Analgesia Disorder; Anesthetic Complication Epidural; Adverse Reaction to Epidural Anesthesia	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 Design

• Study Type: Observational
• Actual Enrollment: 364 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery in Siriraj Hospital
• Study Start Date: December 2014
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Groups and Cohorts

Intervention Details:

• Procedure: Elective Thoracic and Abdominal Surgery Patients
  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.
  Other Name: Epidural Analgesia

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7 [ Time Frame: at postoperative 24 hours ]

   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.

Secondary Outcome Measures :

1. Number of Patients Requiring Rescue Analgesic Medication [ Time Frame: during the period of retaining of epidural catheter up to 3 days after operation ]
   Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation
2. Duration Retaining Epidural Catheter [ Time Frame: the period of retaining of epidural catheter up to 3 days after operation ]
   Duration retaining epidural catheter in hospital
3. All Adverse Effects and Postoperative Complications. [ Time Frame: the period of retaining of epidural catheter up to 3 days after operation ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Thailand

Siriraj Hospital

Bangkok, Thailand, 10700

Sponsors and Collaborators

Siriraj Hospital

Investigators

• Principal Investigator: Mingkwan Wongyingsinn, MD, MSc; Siriraj Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Mingkwan Wongyingsinn, MD, Assistant professor, Doctor, Siriraj Hospital
• ClinicalTrials.gov Identifier: NCT02315261
• Other Study ID Numbers: SIRB004
• First Posted: December 11, 2014
• Results First Posted: November 13, 2018
• Last Update Posted: November 13, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Mingkwan Wongyingsinn, MD, Siriraj Hospital:

Epidural analgesia; Pain score