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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479320
• Other study ID #: IRC/1078/017
• Status: Completed
• Phase: Phase 4
• Start date: March 28, 2018
• Est. completion date: March 27, 2019

Study information

• Verified date: April 2019
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 27, 2019
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Lidocaine
Postoperative analgesic effects will be compared between lidocaine and normal saline group
• Placebo
Postoperative anlagesic requirements will be calculated and compared with experimental group

Locations

Country	Name	City	State
Nepal	B. P. Koirala Institute of Health Sciences	Dharan Bazar

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

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