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

NCT04920019 | Completed

• 1 other identifier: si 800/2020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatoma; Pancreas Cancer

Keywords

open upper abdominal surgery; continuous epidural analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Pain intensity

  postoperative 6 hours until 72 hours postoperative

• Intraoperative opioid usage

  intraoperative

• Complications of thoracic epidural analgesia

  postoperative 24 hours, 48 hours, 72 hours

• Percentage of patient to do out of bed activities

  postoperative day 1

• Length of hospital stay

  days from patient admission until discharge, an average within 1 week

Study Arms (2)

Thoracic continuous epidural analgesia

EXPERIMENTAL

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

No CEA

ACTIVE COMPARATOR

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

Interventions

Thoracic continuous epidural analgesia PROCEDURE

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; Thoracic continuous epidural analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years
• open upper abdominal surgery
• American Society of Anesthesiologists (ASA) grade I-III

You may not qualify if:

• contraindications to CEA
• inability communication
• patient's refusal
• emergency surgery
• BMI \> 35

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (5)

• 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.

  PMID: 27870743 RESULT

• 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.

  PMID: 30161292 RESULT

• 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.

  PMID: 31672606 RESULT

• 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.

  PMID: 30677524 RESULT

• 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.

  PMID: 31592509 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Suwimon Tangwiwat, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized group of patient is identified and sealed in envelope. Postoperative outcomes are assessed by Acute Pain Service nurse or resident.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, Department of Anesthesiology

Model Details: Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 9, 2021
• Study Start: October 22, 2020
• Primary Completion: August 20, 2023
• Study Completion: August 20, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)