Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antioquias Univervesity Health Institution

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Epidural Analgesia

Procedure

The epidural infusion will be as follows:

  • Isobaric Bupivacaine 0.5% 40 cc
  • Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
  • Saline solution 0.9% 156 cc.
  • Total Volume: 200 cc.

This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.

The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement.

Lidocaine infusion

Drug

2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.

Primary outcomes

  1. Posoperative Pain

    Time frame: 24 hours after surgery

    Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").

Secondary outcomes

  1. Posoperative Pain

    Time frame: 2, 6, 12, 48 and 72 hours after surgery

    Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").

  2. Posoperative opioid use

    Time frame: 24 hours after surgery

    mg of morphine

  3. Hospital Stay

    Time frame: 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

    days

  4. Perioperative Satisfaction

    Time frame: 24 hours

    Evaluation du Vecu de l'Anesthesie Generale (EVAN G scale). The EVAN questionnaire is composed of 6 dimensions (attention, privacy, information, pain, discomfort and waiting times), which in turn consist of 26 items. Each item is evaluated with in an ordinal scale. The minimum value is 1, meaning the worst value for the item and the maximum value is 5, meaning the better value for the item.

  5. Toxicity by local anesthetics proportion

    Time frame: 24 hours after surgery

    Proportion of patients presenting signs of toxicity by local anesthetics.

    • Metal taste
    • Tinnitus
    • Hypotension (SBP less than 80 mmHg)
    • Tachycardia (FC greater than 130)
    • Bradycardia (FC less than 40)
    • Alterations of the mental state. It is positive for this outcome with 3 signs or if patient presents seizures or coma without a non-surgical or medical cause associated with the patient's clinical status.

  6. Posoperative nausea and vomiting

    Time frame: 24 hours after surgey

    Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • IPS Universitaria-Universidad de Antioquia

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2019
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.