Hepatoma, Pancreas Cancer
Conditions
Keywords
open upper abdominal surgery, continuous epidural analgesia
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.
Interventions
PROCEDUREThoracic 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)
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Randomized group of patient is identified and sealed in envelope. Postoperative outcomes are assessed by Acute Pain Service nurse or resident.
Intervention model description
Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of postoperative opioid consumption | postoperative 24 hours | amount of fentanyl (microgram) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain intensity | postoperative 6 hours until 72 hours postoperative | numerical rating scale 0-10 (0= no pain, 10= worst pain) |
| Morbidity | Up to 30 days postoperative | Myocardial ischemia, pneumonia, deep vein thrombosis |
| Mortality | Up to 30 days postoperative | Death |
| Length of hospital stay | days from patient admission until discharge, an average within 1 week | hospital admission |
Countries
Thailand
Outcome results
None listed