Pain, Postoperative
Conditions
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
Interventions
DRUGLidocaine
Postoperative analgesic effects will be compared between lidocaine and normal saline group
DRUGPlacebo
Postoperative anlagesic requirements will be calculated and compared with experimental group
Sponsors
B.P. Koirala Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Nepal
Outcome results
None listed