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

B

B.P. Koirala Institute of Health Sciences

Status and phase

Completed
Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Placebo
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03479320
IRC/1078/017

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Lidocaine group
Experimental group
Description:
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
Treatment:
Drug: Lidocaine
Placebo
Placebo Comparator group
Description:
They will receive the same volume of 0.9% of normal saline as calculated for the experimental group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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