Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery
- Conditions
- HepatomaPancreas Cancer
- Interventions
- Procedure: Thoracic continuous epidural analgesia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- age 18-80 years
- open upper abdominal surgery
- American Society of Anesthesiologists (ASA) grade I-III
- contraindications to CEA
- inability communication
- patient's refusal
- emergency surgery
- BMI > 35
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thoracic continuous epidural analgesia 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 morphine 0.02 ug/ml 5 ml/h, morphine 2 mg epidurally are given. Postoperative: 0.0625% bupivacaine with morphine 0.02 ug/ml 5 ml/h is given combined with 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 every 6 hours total 3 days, Parecoxib 40 mg IV x 4 doses then COX2 inhibitor (etoricoxib 90 mg orally x2 days) No CEA Thoracic continuous epidural analgesia 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 hours total 3 days, Parecoxib 40 mg IV x 4 doses then COX2 inhibitor (Etoricoxib 90 mg orally x2 days)
- Primary Outcome Measures
Name Time Method Amount of postoperative opioid consumption postoperative 72 hours amount of fentanyl (microgram)
- Secondary Outcome Measures
Name Time Method 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
Pain intensity postoperative 6 hours until 72 hours postoperative numerical rating scale 0-10 (0= no pain, 10= worst pain)
Complications of thoracic epidural analgesia postoperative 24 hours, 48 hours, 72 hours hypotension, pruritus
Morbidity Up to 30 days postoperative Myocardial ischemia, pneumonia, deep vein thrombosis
Mortality Up to 30 days postoperative Death
Trial Locations
- Locations (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
🇹🇭Bangkok Noi, Bangkok, Thailand