Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery
NCT ID: NCT04920019
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2020-10-22
2023-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Thoracic continuous epidural analgesia
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)
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 hours total 3 days, Parecoxib 40 mg IV x 4 doses then COX2 inhibitor (Etoricoxib 90 mg orally x2 days)
Thoracic continuous epidural analgesia
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)
Interventions
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Thoracic continuous epidural analgesia
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)
Eligibility Criteria
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Inclusion Criteria
* open upper abdominal surgery
* American Society of Anesthesiologists (ASA) grade I-III
Exclusion Criteria
* inability communication
* patient's refusal
* emergency surgery
* BMI \> 35
18 Years
80 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Suwimon Tangwiwat
associate professor, Department of Anesthesiology
Principal Investigators
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Suwimon Tangwiwat, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand
Countries
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References
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Guay J, Nishimori M, Kopp SL. Epidural Local Anesthetics Versus Opioid-Based Analgesic Regimens for Postoperative Gastrointestinal Paralysis, Vomiting, and Pain After Abdominal Surgery: A Cochrane Review. Anesth Analg. 2016 Dec;123(6):1591-1602. doi: 10.1213/ANE.0000000000001628.
Salicath JH, Yeoh EC, Bennett MH. Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. Cochrane Database Syst Rev. 2018 Aug 30;8(8):CD010434. doi: 10.1002/14651858.CD010434.pub2.
Greco KJ, Brovman EY, Nguyen LL, Urman RD. The Impact of Epidural Analgesia on Perioperative Morbidity or Mortality after Open Abdominal Aortic Aneurysm Repair. Ann Vasc Surg. 2020 Jul;66:44-53. doi: 10.1016/j.avsg.2019.10.054. Epub 2019 Oct 28.
Simpson RE, Fennerty ML, Colgate CL, Kilbane EM, Ceppa EP, House MG, Zyromski NJ, Nakeeb A, Schmidt CM. Post-Pancreaticoduodenectomy Outcomes and Epidural Analgesia: A 5-year Single-Institution Experience. J Am Coll Surg. 2019 Apr;228(4):453-462. doi: 10.1016/j.jamcollsurg.2018.12.038. Epub 2019 Jan 21.
Groen JV, Khawar AAJ, Bauer PA, Bonsing BA, Martini CH, Mungroop TH, Vahrmeijer AL, Vuijk J, Dahan A, Mieog JSD. Meta-analysis of epidural analgesia in patients undergoing pancreatoduodenectomy. BJS Open. 2019 Apr 29;3(5):559-571. doi: 10.1002/bjs5.50171. eCollection 2019 Oct.
Other Identifiers
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si 800/2020
Identifier Type: -
Identifier Source: org_study_id
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