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

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04920019

Collaborator

(none)

140

Enrollment

Location

Arms

24.4

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatoma Pancreas Cancer	Procedure: Thoracic continuous epidural analgesia	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Group A: continuous epidural analgesia, Group B: no continuous epidural analsesiaGroup 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thoracic continuous epidural analgesia 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 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)
Active Comparator: intravenous opioid 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 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)

Arm

Intervention/Treatment

Experimental: Thoracic continuous epidural analgesia

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

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)

Active Comparator: intravenous opioid

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

Outcome Measures

Primary Outcome Measures

Amount of postoperative opioid consumption [postoperative 24 hours]
amount of fentanyl (microgram)
Amount of postoperative opioid consumption [postoperative 48 hours]
amount of fentanyl (microgram)
Amount of postoperative opioid consumption [postoperative 72 hours]
amount of fentanyl (microgram)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok	Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suwimon Tangwiwat, associate professor, Department of Anesthesiology, Mahidol University

ClinicalTrials.gov Identifier:

NCT04920019

Other Study ID Numbers:

si 800/2020

First Posted:

Jun 9, 2021

Last Update Posted:

Jun 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suwimon Tangwiwat, associate professor, Department of Anesthesiology, Mahidol University

open upper abdominal surgery

continuous epidural analgesia

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jun 9, 2021