|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03479320 |
|
Date of registration:
|
15/03/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation
|
|
Scientific title:
|
Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia |
|
Date of first enrolment:
|
March 28, 2018 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03479320 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Nepal
| | | | | | | |
|
Contacts
|
|
Name:
|
Vivek Kr Mahato, BDS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
BP Koirala Institute of health sciences |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain, Postoperative
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Lidocaine
|
|
Primary Outcome(s)
|
|
Postoperative Numeric Rating Scale(NRS)
[Time Frame: 24 hours]
|
|
Secondary Outcome(s)
|
|
Side effects
[Time Frame: 24 hours]
|
|
Time to first analgesic request
[Time Frame: 24 hours]
|
|
Total opioid consumption
[Time Frame: 24 hours]
|
|
Secondary ID(s)
|
|
IRC/1078/017
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|