A Phase 4 interventional study of Epidural Analgesia and Lidocaine Infusion in Pain, Postoperative and Opioid Use, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-26.
Sponsored by Universidad de Antioquia · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 210 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
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Elective major open intra-abdominal surgery:
Exclusion Criteria:
Patient with contraindication for epidural analgesic techniques:
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
Intravenous lidocaine
Drug: Lidocaine Infusion
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.
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
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").
Time frame: 24 hours after surgery
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").
Time frame: 2, 6, 12, 48 and 72 hours after surgery
Posoperative opioid use
mg of morphine
Time frame: 24 hours after surgery
Hospital Stay
days
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
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.
Time frame: 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.
Time frame: 24 hours after surgery
Posoperative nausea and vomiting
Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.
Time frame: 24 hours after surgey
Plan to share: No
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Universidad de Antioquia