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2020-10-22
2023-08-20
2023-08-20
140
NCT04920019
Mahidol University
Mahidol University
INTERVENTIONAL
Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-05-21 | N/A | 2023-08-20 |
2021-06-08 | N/A | 2023-08-23 |
2021-06-09 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Thoracic continuous epidural analgesia Thoracic continuous epidural analgesia at T7-8 or T8-9 combined with IV PCA fentanyl (bolus mode only 15 ug/bolus, 5 minutes lockout, 4 hours limit 200 ug). Multimodal analgesia Intraoperative : thoracic epidural infusion with 0.0625% bupivacaine with mo | PROCEDURE: Thoracic continuous epidural analgesia
|
| ACTIVE_COMPARATOR: No CEA IV PCA fentanyl, IV patient-controlled analgesia; bolus mode only, fentanyl 15 ug/bolus, lockout interval 5 minutes, 4 hours limit 200ug multimodal analgesia: paracetamol 1000 mg IV every 6 hours until patient can take orally, change to 1000 mg orally q 6 | PROCEDURE: Thoracic continuous epidural analgesia
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Amount of postoperative opioid consumption | amount of fentanyl (microgram) | postoperative 24 hours |
| Amount of postoperative opioid consumption | amount of fentanyl (microgram) | postoperative 48 hours |
| Amount of postoperative opioid consumption | amount of fentanyl (microgram) | postoperative 72 hours |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pain intensity | numerical rating scale 0-10 (0= no pain, 10= worst pain) | postoperative 6 hours until 72 hours postoperative |
| Intraoperative opioid usage | intravenous fentanyl consumption | intraoperative |
| Complications of thoracic epidural analgesia | hypotension, pruritus | postoperative 24 hours, 48 hours, 72 hours |
| Percentage of patient to do out of bed activities | standing beside the patient's bed | postoperative day 1 |
| Length of hospital stay | hospital admission | days from patient admission until discharge, an average within 1 week |
| Morbidity | Myocardial ischemia, pneumonia, deep vein thrombosis | Up to 30 days postoperative |
| Mortality | Death | Up to 30 days postoperative |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
