Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.

Detailed Description
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Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.

Official Title
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Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Lidocaine,
* Drug: Ketamine
* Drug: association ketamine-lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: abdominal surgery by laparotomy Exclusion Criteria: laparoscopy history of chronic pain opioid self-administration psychiatric disorders difficulties with communication renal or hepatic dysfunction ASA physical status > 3

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours | Drug: Lidocaine,<br>* Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.<br>|
| Active Comparator: Ketamine<br>Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours | Drug: Ketamine<br>* Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.<br>|
| Active Comparator: Ketamine-Lidocaine<br>Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours. | Drug: association ketamine-lidocaine<br>* Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.<br>|
| Placebo Comparator: Saline 0,9%<br>Control group | Drug: Placebo<br>* The control group (C) received an equal volume of saline 0.9 % during 48 h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative morphine consumption | Cumulative morphine consumption over 48 hours postoperatively | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Pain scores at rest and movement | 48 hours | 
| Mechanical hyperalgesia | Mechanical hyperalgesia using pressure algometry | 48 hours | 
| Occurrence of side effects | Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, postoperative care, intravenous lidocaine, intravenous ketamine, morphine consumption