Back to results

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

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 4

Locations

Nepal

Study Type

Interventional

Intervention

Lidocaine

Placebo

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

B. P. Koirala Institute of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine group

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total opioid consumption

Total morphine or morphine equivalent in milligram

Time to first analgesic request

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

Side effects

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

Full Information

NCT ID

NCT03479320

First Posted

March 15, 2018

Last Updated

April 6, 2019

Sponsor

B.P. Koirala Institute of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03479320

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 28, 2018 (Actual)

Primary Completion Date

December 27, 2018 (Actual)

Study Completion Date

March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

B.P. Koirala Institute of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine group

Arm Type

Experimental

Arm 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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Postoperative anlagesic requirements will be calculated and compared with experimental group

Primary Outcome Measure Information:

Title

Postoperative Numeric Rating Scale(NRS)

Description

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Total opioid consumption

Description

Total morphine or morphine equivalent in milligram

Time Frame

24 hours

Title

Time to first analgesic request

Description

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

Time Frame

24 hours

Title

Side effects

Description

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

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivek Kr Mahato, BDS

Organizational Affiliation

BP Koirala Institute of Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

B. P. Koirala Institute of Health Sciences

City

Dharān Bāzār

ZIP/Postal Code

34464

Country

Nepal

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs