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The aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach
In a recent Cochrane Library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied.
More studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology For this reason, the investigators have designed a randomized, double-blind, phase IV clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated.
This study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIDOCAINE | Experimental | 2% lidocaine will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine. The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient |
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| PLACEBO | Placebo Comparator | 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction . After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine/placebo. The study medication will be prepared in a 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing Physiological Serum as assigned by the patient. The syringes prepared by the pharmacy will be identical in all cases, with a label specifying the title of this test and the identification number of the patient |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Iv | Drug | 2% lidocaine or 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine. 20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine . |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid consumption | o evaluate the effect of intravenous lidocaine on postoperative pain after laparoscopic upper abdominal cancer surgery, analyzing postoperative opioid consumption | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nausea and vomiting | Analyze the incidence of nausea and vomiting, paralytic ileus, time of return to oral diet and hospital stay. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillem Pla, MD | Hospital Dr Josep Trueta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dr Josep Trueta | Girona | 17007 | Spain |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial
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Patients will be randomized in a 1: 1 ratio to one of two treatment groups: Lidocaine or Placebo.
To preserve the masking of the study, the list with the recruited patients will be sent weekly to an independent researcher from IDIBGI, who will be in charge of providing the names and numbers of the medical records to the pharmacy service.
The randomization process has been carried out using the PASS 16.0.4 program. Only the Pharmacy staff will know the randomization tables and codes. The main investigator will have the emergency codes in case of need
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |