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

Universidad de Antioquia

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative; Opioid Use

Treatments: Procedure: Epidural Analgesia; Drug: Lidocaine Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04017013

SIIU 2001-15550

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups

Epidural Analgesia

Active Comparator group

Description:

The placement of the thoracic epidural catheter will be located depending on surgical incision as follows: * Surgery of the upper abdomen: T7-T8. * Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol.

Treatment:

Procedure: Epidural Analgesia

Lidocaine Infussion

Experimental group

Description:

Intravenous lidocaine

Treatment:

Drug: Lidocaine Infusion