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NCT Number: NCT04920019

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

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.

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Key information

Conditions

Hepatoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Amount of postoperative opioid consumption

    Time frame: postoperative 24 hours

    amount of fentanyl (microgram)

  2. Amount of postoperative opioid consumption

    Time frame: postoperative 48 hours

    amount of fentanyl (microgram)

  3. Amount of postoperative opioid consumption

    Time frame: postoperative 72 hours

    amount of fentanyl (microgram)

Secondary outcomes

  1. Pain intensity

    Time frame: postoperative 6 hours until 72 hours postoperative

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

  2. Intraoperative opioid usage

    Time frame: intraoperative

    intravenous fentanyl consumption

  3. Complications of thoracic epidural analgesia

    Time frame: postoperative 24 hours, 48 hours, 72 hours

    hypotension, pruritus

  4. Percentage of patient to do out of bed activities

    Time frame: postoperative day 1

    standing beside the patient's bed

  5. Length of hospital stay

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

    hospital admission

  6. Morbidity

    Time frame: Up to 30 days postoperative

    Myocardial ischemia, pneumonia, deep vein thrombosis

  7. Mortality

    Time frame: Up to 30 days postoperative

    Death

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2021
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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