Opioid Use, Pain, Postoperative
Conditions
Keywords
Pain, Abdominal Surgery, Epidural analgesia, lidocaine
Brief summary
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.
Interventions
PROCEDUREEpidural 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.
DRUGLidocaine Infusion
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
Sponsors
IPS Universitaria-Universidad de Antioquia
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The masking process will be done as follows: Masking of the data collection and analysis staff: The investigative staff who performs the data collection and who evaluates the outcomes after the anesthetic act, will not have information about the intervention received by the patient. Those who participate in the data analysis phase will also be blind to the intervention. For practical and ethical point of view, it is not possible to mask the doctors who perform the intervention and neither the patients. A SHAM or simulated intervention is not possible given that this would require an unnecessary invasive procedure that would not be used, which would make it ethically questionable.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posoperative Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Posoperative opioid use | 24 hours after surgery | mg of morphine |
| Hospital Stay | 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 |
| Posoperative Pain | 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). |
| Toxicity by local anesthetics proportion | 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. |
| Posoperative nausea and vomiting | 24 hours after surgey | Proportion of patients with at least one episode of nausea or vomiting in the postoperative period. |
| Perioperative Satisfaction | 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. |
Countries
Colombia
Outcome results
None listed