Clinical trial NCT04017013: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Opioid Use
Keywords: Pain
Abdominal Surgery
Epidural analgesia
lidocaine
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: IPS Universitaria-Universidad de Antioquia
First posted: 2019-07-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients who accept participation in the study and meet all inclusion criteria will be randomly assigned at the time of anesthetic induction. The assignment to the group of epidural analgesia vs IV lidocaine will be 1: 1 randomly using permuted blocks generated by a computer operated by an external assistant to the investigation. The size of the blocks will be variable between 4, 6, and 8, and will be kept confidential to guarantee the concealment of the groups.
Primary purpose: TREATMENT

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 pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.

The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.

The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.

Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.

The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Pregnant woman
* Patient with contraindication for epidural analgesic techniques:

  1. Anticoagulated patient
  2. Active infection in the puncture site.
  3. Malformation in spinal cord.
  4. Sepsis without antibiotic treatment.
  5. Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
  6. Patient with known allergy to opioids and / or local anesthetics.
  7. Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
  8. Patient with liver failure or terminal renal failure.
  9. Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
  10. Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
  11. Patient who was technically impossible to place an epidural catheter in surgery.

Primary outcomes:
measure: Posoperative Pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Posoperative Pain
timeFrame: 2, 6, 12, 48 and 72 hours after surgery
measure: Posoperative opioid use
timeFrame: 24 hours after surgery
measure: Hospital Stay
timeFrame: From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months
measure: Perioperative Satisfaction
timeFrame: 24 hours
measure: Toxicity by local anesthetics proportion
timeFrame: 24 hours after surgery
measure: Posoperative nausea and vomiting
timeFrame: 24 hours after surgey
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Antioquias Univervesity Health Institution
state: Antioquia
Study officials:
affiliation: Univeridad de Antioquia's Professor
name: Fabian Casas, Dr
role: PRINCIPAL_INVESTIGATOR
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