Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation

Study Overview
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Brief Summary
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This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request

Official Title
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Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 18-60 years of age Patients of ASA (American Society of Anesthesiologists) Class I or Class II (I- healthy with no systemic disease, II- mild systemic disease with no functional limitation) who require oral and maxillofacial surgeries under general anesthesia Exclusion Criteria: Refusal to give consent. Hypersensitivity or allergy to the study medication. ASA physical status III or more. Subjects with known severe hepatic or renal dysfunction or cardiac dysrhythmia or atrioventricular block. History of taking opioids or antiarrhythmic drugs within 1 week of surgery. History of drug or alcohol abuse History of psychiatric disorders. Patients requiring emergency surgery. Patients unable to comprehend pain assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery | Drug: Lidocaine<br>* Postoperative analgesic effects will be compared between lidocaine and normal saline group<br>|
| Placebo Comparator: Placebo<br>They will receive the same volume of 0.9% of normal saline as calculated for the experimental group | Drug: Placebo<br>* Postoperative anlagesic requirements will be calculated and compared with experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Numeric Rating Scale(NRS) | Pain at rest and with cough or movement using the NRS scale, which ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption | Total morphine or morphine equivalent in milligram | 24 hours | 
| Time to first analgesic request | Time to first analgesic (ketorolac) request (time counted after skin closure) | 24 hours | 
| Side effects | Number of patients with light headedness, sedation, nausea, vomiting will be documented | 24 hours |