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HepatomaNCT04920019

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

A study testing Thoracic continuous epidural analgesia in people with Hepatoma and Pancreas Cancer, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatoma, Pancreas Cancer
What is being tested?
Thoracic continuous epidural analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteThailand
Study dates
22 Oct 2020to 20 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

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

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.

Read the 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.

Being tested
Thoracic continuous epidural analgesia
Keywords
open upper abdominal surgery, continuous epidural analgesia
Medical subject headings
Carcinoma, Hepatocellular, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic continuous epidural analgesiaProcedure or surgery

    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)

Study groups in NCT04920019
Study groupRoleWhat they receive
Thoracic continuous epidural analgesiaExperimentalThoracic 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)
Receives: Procedure: Thoracic continuous epidural analgesia
No CEAActive comparatorIV 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)
Receives: Procedure: Thoracic continuous epidural analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of postoperative opioid consumption

    amount of fentanyl (microgram)

    Measured: postoperative 24 hours

  2. Amount of postoperative opioid consumption

    amount of fentanyl (microgram)

    Measured: postoperative 48 hours

  3. Amount of postoperative opioid consumption

    amount of fentanyl (microgram)

    Measured: postoperative 72 hours

Secondary outcomes (7)

  1. Pain intensity

    numerical rating scale 0-10 (0= no pain, 10= worst pain)

    Measured: postoperative 6 hours until 72 hours postoperative

  2. Intraoperative opioid usage

    intravenous fentanyl consumption

    Measured: intraoperative

  3. Complications of thoracic epidural analgesia

    hypotension, pruritus

    Measured: postoperative 24 hours, 48 hours, 72 hours

  4. Percentage of patient to do out of bed activities

    standing beside the patient's bed

    Measured: postoperative day 1

  5. Length of hospital stay

    hospital admission

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

  6. Morbidity

    Myocardial ischemia, pneumonia, deep vein thrombosis

    Measured: Up to 30 days postoperative

  7. Mortality

    Death

    Measured: Up to 30 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start22 Oct 2020
  3. Primary completion20 Aug 2023
  4. Study completion20 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920019
Sponsor's protocol ID
si 800/2020
Status last verified
Aug 2023
First submitted
21 May 2021
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27870743

  • 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.

    PubMed 30161292

  • 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.

    PubMed 31672606

  • 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.

    PubMed 30677524

  • 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.

    PubMed 31592509

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic continuous epidural analgesia in people with Hepatoma and Pancreas Cancer, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of postoperative opioid consumption (time frame: postoperative 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920019, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.

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