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Clinical Trials/NCT04920019
NCT04920019
Completed
Not Applicable

Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery: Prospective Randomized Controlled Trial

Mahidol University1 site in 1 country140 target enrollmentOctober 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatoma
Sponsor
Mahidol University
Enrollment
140
Locations
1
Primary Endpoint
Amount of postoperative opioid consumption
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This prospective randomized controlled study is aimed to determine the advantages of thoracic epidural analgesia for open upper abdominal surgery in combination with multimodal analgesia compared with no thoracic epidural analgesia on postoperative pain control. The primary outcome is total opioid consumption in postoperative 72 hours. Secondary outcomes are the success of continuous epidural analgesia or complications of this technique, pain intensity, morbidity and mortality compare to no continuous epidural analgesia.

Detailed Description

Continuous epidural analgesia (CEA) for open upper abdominal surgery has been showed the analgesic analgesia for open abdominal surgery. However the technical difficulty, complications especially hypotension, pruritus of CEA impede the popularity of technique compared to intravenous patient-controlled analgesia (IV PCA) in multimodal analgesia. This study is aimed to study of the role of CEA and multimodal analgesia in open abdominal surgery compare to IV PCA.

Registry
clinicaltrials.gov
Start Date
October 22, 2020
End Date
August 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suwimon Tangwiwat

associate professor, Department of Anesthesiology

Mahidol University

Eligibility Criteria

Inclusion Criteria

  • age 18-80 years
  • open upper abdominal surgery
  • American Society of Anesthesiologists (ASA) grade I-III

Exclusion Criteria

  • contraindications to CEA
  • inability communication
  • patient's refusal
  • emergency surgery
  • BMI \> 35

Outcomes

Primary Outcomes

Amount of postoperative opioid consumption

Time Frame: postoperative 72 hours

amount of fentanyl (microgram)

Secondary Outcomes

  • Mortality(Up to 30 days postoperative)
  • Intraoperative opioid usage(intraoperative)
  • Length of hospital stay(days from patient admission until discharge, an average within 1 week)
  • Percentage of patient to do out of bed activities(postoperative day 1)
  • Pain intensity(postoperative 6 hours until 72 hours postoperative)
  • Complications of thoracic epidural analgesia(postoperative 24 hours, 48 hours, 72 hours)
  • Morbidity(Up to 30 days postoperative)

Study Sites (1)

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