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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2019-03-27

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

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lidocaine group

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Postoperative analgesic effects will be compared between lidocaine and normal saline group

Placebo

They will receive the same volume of 0.9% of normal saline as calculated for the experimental group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Postoperative anlagesic requirements will be calculated and compared with experimental group

Interventions

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Lidocaine

Postoperative analgesic effects will be compared between lidocaine and normal saline group

Intervention Type DRUG

Placebo

Postoperative anlagesic requirements will be calculated and compared with experimental group

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No