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OpenTrials
Completed

NCT Number: NCT03479320

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

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

B. P. Koirala Institute of Health Sciences

Dharān, 34464, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Placebo

Drug

Postoperative anlagesic requirements will be calculated and compared with experimental group

Primary outcomes

  1. Postoperative Numeric Rating Scale(NRS)

    Time frame: 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 outcomes

  1. Total opioid consumption

    Time frame: 24 hours

    Total morphine or morphine equivalent in milligram

  2. Time to first analgesic request

    Time frame: 24 hours

    Time to first analgesic (ketorolac) request (time counted after skin closure)

  3. Side effects

    Time frame: 24 hours

    Number of patients with light headedness, sedation, nausea, vomiting will be documented

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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