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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920019
• Other study ID #: si 800/2020
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: August 20, 2023

Study information

• Verified date: August 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View Citation

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. — View Citation

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: 10.1 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of postoperative opioid consumption	amount of fentanyl (microgram)	postoperative 24 hours
Primary	Amount of postoperative opioid consumption	amount of fentanyl (microgram)	postoperative 48 hours
Primary	Amount of postoperative opioid consumption	amount of fentanyl (microgram)	postoperative 72 hours
Secondary	Pain intensity	numerical rating scale 0-10 (0= no pain, 10= worst pain)	postoperative 6 hours until 72 hours postoperative
Secondary	Intraoperative opioid usage	intravenous fentanyl consumption	intraoperative
Secondary	Complications of thoracic epidural analgesia	hypotension, pruritus	postoperative 24 hours, 48 hours, 72 hours
Secondary	Percentage of patient to do out of bed activities	standing beside the patient's bed	postoperative day 1
Secondary	Length of hospital stay	hospital admission	days from patient admission until discharge, an average within 1 week
Secondary	Morbidity	Myocardial ischemia, pneumonia, deep vein thrombosis	Up to 30 days postoperative
Secondary	Mortality	Death	Up to 30 days postoperative