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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatoma, Pancreas Cancer

Intervention / Treatment
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* Procedure: Thoracic continuous epidural analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracic continuous epidural analgesia<br>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) | Procedure: Thoracic continuous epidural analgesia<br>* Continuous epidural catheter (Portex ™, Epidural Minipack , Smiths Medical), infused with 0.0625% bupivacaine (Marcaine™, Aspen Holdings) with morphine (morphine M&H™) 0.02 mg/ml 5 ml/h postoperative until POD3 morning Connected with The Sapphire ™ Infusion System Patient-Controlled-Analgesia (PCA) pump(fentanyl (fentanyl-Hameln™, Siam Bioscience): intravenous bolus mode only 15 ug/bolus, lockout interval 5 minutes, 4-hour limit 200 ug) Postoprative analgesia: intravenous paracetamol (infulgan ™, Yuria-Pharm), tablet paracetamol (SaRa ™), Parecoxib (Dynastat ™, Pfizer), Etoricoxib (Arcoxia ™, MSD)<br>|
| Active Comparator: No CEA<br>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) | Procedure: Thoracic continuous epidural analgesia<br>* Continuous epidural catheter (Portex ™, Epidural Minipack , Smiths Medical), infused with 0.0625% bupivacaine (Marcaine™, Aspen Holdings) with morphine (morphine M&H™) 0.02 mg/ml 5 ml/h postoperative until POD3 morning Connected with The Sapphire ™ Infusion System Patient-Controlled-Analgesia (PCA) pump(fentanyl (fentanyl-Hameln™, Siam Bioscience): intravenous bolus mode only 15 ug/bolus, lockout interval 5 minutes, 4-hour limit 200 ug) Postoprative analgesia: intravenous paracetamol (infulgan ™, Yuria-Pharm), tablet paracetamol (SaRa ™), Parecoxib (Dynastat ™, Pfizer), Etoricoxib (Arcoxia ™, MSD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open upper abdominal surgery, continuous epidural analgesia