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

N/ACompletedNCT04920019

Mahidol University140 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Hepatoma Pancreas Cancer

Interventions

Thoracic continuous epidural analgesiaPROCEDURE

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Outcomes

Primary Outcomes

Amount of postoperative opioid consumption

amount of fentanyl (microgram)

Time frame: postoperative 24 hours

Amount of postoperative opioid consumption

amount of fentanyl (microgram)

Time frame: postoperative 48 hours

Amount of postoperative opioid consumption

amount of fentanyl (microgram)

Time frame: postoperative 72 hours

Secondary Outcomes

Pain intensity

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

Time frame: postoperative 6 hours until 72 hours postoperative

Intraoperative opioid usage

intravenous fentanyl consumption

Time frame: intraoperative

Complications of thoracic epidural analgesia

hypotension, pruritus

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

Percentage of patient to do out of bed activities

standing beside the patient's bed

Time frame: postoperative day 1

Length of hospital stay

hospital admission

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

Morbidity

Myocardial ischemia, pneumonia, deep vein thrombosis

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.