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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005799-90 | EudraCT Number |
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Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption.
This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours.
Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine 20mg/ml | Experimental | Patients in Lidocaine group received an intravenous bolus injection of 1,5 mg/kg lidocaine (0,075mL/kg of Lidocaine 20mg/mL) followed by a continuous lidocaine infusion of 2 mg/kg/hr during surgery (0,1mL/kg/hr of Lidocaine 20mg/mL) and 1 mg/kg/hr in recovery room (0,05mL/kg/hr of Lidocaine 20mg/mL). |
|
| Glucose 5% (placebo) | Placebo Comparator | Patients in control group received an intravenous bolus injection of 0,075mL/kg of placebo (Glucose 5%) by a continuous lidocaine infusion of 0,1mL/kg/hr of placebo (Glucose 5%) during surgery and 0,05mL/kg/hr of placebo (Glucose 5%) in recovery room. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 20mg/ml | Drug | Patients in Lidocaine group received an intravenous bolus injection of 1,5 mg/kg lidocaine (0,075mL/kg of Lidocaine 20mg/mL) followed by a continuous lidocaine infusion of 2 mg/kg/hr during surgery (0,1mL/kg/hr of Lidocaine 20mg/mL) and 1 mg/kg/hr in recovery room (0,05mL/kg/hr of Lidocaine 20mg/mL). |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine requirement during the first 48 postoperative hours | Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour. | 48 postoperative hours (H48) |
| Measure | Description | Time Frame |
|---|---|---|
| Remifentanil peroperative consumption | from the beginning of anesthesia to end of surgery | At the end of surgery (an average of 3 hours et 10 minutes) |
| Total morphine requirement | Total morphine requirement during the first 24 postoperative hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon / Hôpital de la Croix Rousse | Lyon | 69004 | France | |||
| Centre Léon Bérard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30987664 | Background | Omar E, Wallon G, Bauer C, Axiotis G, Bouix C, Soubirou JL, Aubrun F. Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial. Trials. 2019 Apr 15;20(1):220. doi: 10.1186/s13063-019-3303-x. | |
| 35852564 | Result | Wallon G, Erbacher J, Omar E, Bauer C, Axiotis G, Thevenon S, Soubirou JL, Aubrun F. Effect of intravenous lidocaine on pain after head and neck cancer surgery (ELICO trial): A randomised controlled trial. Eur J Anaesthesiol. 2022 Sep 1;39(9):735-742. doi: 10.1097/EJA.0000000000001712. Epub 2022 Jul 20. |
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|
| Glucose 5% (placebo) | Drug | Patients in control group received an intravenous bolus injection of 0,075mL/kg of placebo (Glucose 5%) by a continuous lidocaine infusion of 0,1mL/kg/hr of placebo (Glucose 5%) during surgery and 0,05mL/kg/hr of placebo (Glucose 5%) in recovery room. |
|
| 24 postoperative hours (H24) |
| Evaluation of chronic post-surgical pain | Chronic post-surgical pain will be evaluated from 3 to 6 month after surgery by a personal interview of each patient with the french version of McGill pain questionnaire (Questionnaire de Saint-Antoine - version abrégée) | 3 to 6 months after surgery (M3-6) |
| Incidence of side effects that can be attributed to lidocaine infusion | 3 to 6 months after surgery (M3-6) |
| Lyon |
| 69008 |
| France |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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