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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Procedure: Epidural Analgesia
* Drug: Lidocaine Infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Analgesia<br>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<br>* 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.<br>|
| Experimental: Lidocaine Infussion<br>Intravenous lidocaine | Drug: Lidocaine Infusion<br>* 2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posoperative Pain | 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 | 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 | mg of morphine | 24 hours after surgery | 
| Hospital Stay | 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 | 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 | 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 | Proportion of patients with at least one episode of nausea or vomiting in the postoperative period. | 24 hours after surgey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Abdominal Surgery, Epidural analgesia, lidocaine