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

Primary Purpose

Hepatoma, Pancreas Cancer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Thoracic continuous epidural analgesia
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatoma focused on measuring open upper abdominal surgery, continuous epidural analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thoracic continuous epidural analgesia

No CEA

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Amount of postoperative opioid consumption
amount of fentanyl (microgram)
Amount of postoperative opioid consumption
amount of fentanyl (microgram)
Amount of postoperative opioid consumption
amount of fentanyl (microgram)

Secondary Outcome Measures

Pain intensity
numerical rating scale 0-10 (0= no pain, 10= worst pain)
Intraoperative opioid usage
intravenous fentanyl consumption
Complications of thoracic epidural analgesia
hypotension, pruritus
Percentage of patient to do out of bed activities
standing beside the patient's bed
Length of hospital stay
hospital admission
Morbidity
Myocardial ischemia, pneumonia, deep vein thrombosis
Mortality
Death

Full Information

First Posted
May 21, 2021
Last Updated
August 20, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04920019
Brief Title
Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery
Official Title
Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery: Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatoma, Pancreas Cancer
Keywords
open upper abdominal surgery, continuous epidural analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia
Masking
None (Open Label)
Masking Description
Randomized group of patient is identified and sealed in envelope. Postoperative outcomes are assessed by Acute Pain Service nurse or resident.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27870743
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: 10.1213/ANE.0000000000001628.
Results Reference
result
PubMed Identifier
30161292
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.
Results Reference
result
PubMed Identifier
31672606
Citation
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.
Results Reference
result
PubMed Identifier
30677524
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: 10.1016/j.jamcollsurg.2018.12.038. Epub 2019 Jan 21.
Results Reference
result
PubMed Identifier
31592509
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. eCollection 2019 Oct.
Results Reference
result

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

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