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

September 23, 2022 updated by: Universidad de Antioquia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Antioquias Univervesity Health Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Epidural Analgesia

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.
Procedure: Epidural Analgesia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, 6, 12, 48 and 72 hours after surgery
Posoperative opioid use
Time Frame: 24 hours after surgery
mg of morphine
24 hours after surgery
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
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
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.
24 hours
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.
24 hours after surgery
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.
24 hours after surgey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Collaborators

IPS Universitaria-Universidad de Antioquia

Investigators

  • Principal Investigator: Fabian Casas, Dr, Univeridad de Antioquia's Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

September 5, 2022

Study Completion (ACTUAL)

September 5, 2022

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (ACTUAL)

July 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIIU 2001-15550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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