Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery

Not Applicable

Completed

• Conditions: Hepatoma; Pancreas Cancer

• Registration Number: NCT04920019
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2020-10-22
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-09
• Status Verified: 2023-08
• Primary Completion: 2023-08-20
• Study Completion: 2023-08-20
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of postoperative opioid consumption	postoperative 72 hours	amount of fentanyl (microgram)

Secondary Outcome Measures

Name	Time	Method
Pain intensity	postoperative 6 hours until 72 hours postoperative	numerical rating scale 0-10 (0= no pain, 10= worst pain)
Morbidity	Up to 30 days postoperative	Myocardial ischemia, pneumonia, deep vein thrombosis
Mortality	Up to 30 days postoperative	Death
Intraoperative opioid usage	intraoperative	intravenous fentanyl consumption
Length of hospital stay	days from patient admission until discharge, an average within 1 week	hospital admission
Percentage of patient to do out of bed activities	postoperative day 1	standing beside the patient's bed
Complications of thoracic epidural analgesia	postoperative 24 hours, 48 hours, 72 hours	hypotension, pruritus

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand