Lidocaine and Analgesia After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy

Detailed Description
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Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct. Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Official Title
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Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain, Opioid Consumption

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II Age ≥ 18 years old BMI ≤ 35 Exclusion Criteria: Allergy in local anesthetics History of liver, kidney or heart failure Existence of chronic pain history or daily analgesics Psychiatric disorders Inability to understand pain assessment

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Intraoperative administration of lidocaine to patients undergo laparoscopic cholecystectomy. Prior induction to anesthesia, lidocaine bolus 1.5 mg / kg will be administered to the lidocaine group and then patients will be connected to a continuous 2 mg / kg / h administration of lidocaine until the end of the procedure. | Drug: Lidocaine<br>* Intraoperative administration of lidocaine<br>|
| Placebo Comparator: Placebo<br>Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy. | Drug: Placebo<br>* Intraoperative administration of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | The total dose of tramadol is calculated as mg and administered intravenously. | 24 hours after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain) | Departure of the patient from the recovery room (0hrs) | 
| Postoperative pain | Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain) | 6 hrs after the procedure | 
| Postoperative pain | Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain) | 12 hrs after the procedure | 
| Postoperative pain | Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain) | 24 hrs after the procedure | 
| Incidence of Nausea and Vomiting | The percentage of patients who had nausea and vomiting during the first 24 hours | 24 hours | 
| Incidence of sedation and respiratory depression | The percentage of patients who had sedation and respiratory depression during the first 24 hours | 24 hours | 
| Incidence of shoulder pain | The percentage of patients who had shoulder pain during the first24 hours | 24 hours | 
| Incidence of headache and dizziness | The percentage of patients who had headache and dizziness during the first 24 hours | 24 hours | 
| Change from baseline Mean Blood Pressure | Non-invasive blood pressure measurement by using sphygmomanometer cuff | Intraoperative | 
| Change from Baseline Heart Rate | Bradycardia, tachycardia during the procedure | Intraoperative | 
| Change in depth of anesthesia | Maintenance of Bispectral index (BIS) values of 40 to 50 | Intraoperative | 
| Side effect related to administration of lidocaine | The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Postoperative Pain, Opioid consumption, Laparoscopic cholecystectomy