Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery: Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Amount of postoperative opioid consumption
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Randomized group of patient is identified and sealed in envelope. Postoperative outcomes are assessed by Acute Pain Service nurse or resident.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Suwimon Tangwiwat
associate professor, Department of Anesthesiology
Mahidol University