Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery

Study Overview
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Brief Summary
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Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period. Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery. Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.

Official Title
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Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery

Conditions
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Abdominal Surgery by Laparotomy, Thoracic Epidural Analgesia, Analgesia, Lidocaine Adverse Reaction

Intervention / Treatment
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* Other: Blood sample
* Drug: Lidocain
* Drug: ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal surgery by laparotomy Exclusion Criteria: laparoscopic abdominal surgery, TEA contraindication, ropivacaine contraindication intravenous lidocaine contraindication

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thoracic epidural analgesia<br>Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period | Other: Blood sample<br>* Lidocaine blood sample 30 min before the end of the surgery Lidocaine blood sample at the end of the infusion lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA Ropivacaine blood sample 24h after the infusion of the TEA<br>Drug: Lidocain<br>* Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end) The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.<br>Drug: ropivacaine<br>* Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lidocaine concentration (micrograms/ml) | Lidocaine blood sample will be performed 30 min before the end of the surgery | 30 minutes before the end of surgery | 
| blood lidocaine concentration (micrograms/ml) | lidocaine blood sample will be performed at the end of the infusion, | at the end of the surgery (assessed up to 2 hours) | 
| blood lidocaine and ropivacaine concentration (micrograms/ml) | lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA, | at 2 hours | 
| blood ropivacaine concentration (micrograms/ml) | ropivacaine blood sample 24h after the infusion of the TEA | at 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic epidural analgesia, Abdominal surgery by laparotomy, Analgesia, Lidocaine Adverse Reaction