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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Lidocaine; Drug: Placebo

• Registration Number: NCT03479320
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-24
• Study First Posted: 2018-03-27
• Study Start: 2018-03-28
• Primary Completion: 2018-12-27
• Study Completion: 2019-03-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-06
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine	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
Placebo	Placebo	They will receive the same volume of 0.9% of normal saline as calculated for the experimental group

Primary Outcome Measures

Name	Time	Method
Postoperative Numeric Rating Scale(NRS)	24 hours	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

B. P. Koirala Institute of Health Sciences; 🇳🇵 Dharān Bāzār, Nepal