Status:
COMPLETED
Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
Lead Sponsor:
Universidad de Antioquia
Collaborating Sponsors:
IPS Universitaria-Universidad de Antioquia
Conditions:
Pain, Postoperative
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pa...
Eligibility Criteria
Inclusion
- Patient over 18 years.
- Elective major open intra-abdominal surgery:
- Cholecystectomy.
- Total or subtotal gastrectomy.
- Colectomy or Hemicolectomy.
- Pancreatoduodenectomy.
- Hepatectomy 1 or 2 segments.
- Exploration and / or reconstruction of the bile duct.
- Abdominal demolition.
- Sigmoidectomy.
- Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.
Exclusion
- Pregnant woman
- Patient with contraindication for epidural analgesic techniques:
- Anticoagulated patient
- Active infection in the puncture site.
- Malformation in spinal cord.
- Sepsis without antibiotic treatment.
- Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
- Patient with known allergy to opioids and / or local anesthetics.
- Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
- Patient with liver failure or terminal renal failure.
- Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
- Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
- Patient who was technically impossible to place an epidural catheter in surgery.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2022
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04017013
Start Date
March 1 2020
End Date
September 5 2022
Last Update
September 26 2022
Active Locations (1)
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1
Antioquias Univervesity Health Institution
Medellín, Antioquia, Colombia