Pain, PostoperativePhase 4NCT03479320
Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation
A Phase 4 study testing Lidocaine in people with Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNepal
- Study dates
- 28 Mar 2018to 27 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of psychiatric disorders.
- Patients requiring emergency surgery.
- Patients unable to comprehend pain assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia
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
- Conditions
- Pain, Postoperative
- Being tested
- Lidocaine, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Postoperative analgesic effects will be compared between lidocaine and normal saline group
PlaceboDrug
Postoperative anlagesic requirements will be calculated and compared with experimental group
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | 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 Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | They will receive the same volume of 0.9% of normal saline as calculated for the experimental group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (3)
Total opioid consumption
Total morphine or morphine equivalent in milligram
Measured: 24 hours
Time to first analgesic request
Time to first analgesic (ketorolac) request (time counted after skin closure)
Measured: 24 hours
Side effects
Number of patients with light headedness, sedation, nausea, vomiting will be documented
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start28 Mar 2018
- Primary completion27 Dec 2018
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vivek Kumar Mahato, B.P. Koirala Institute of Health Sciences
- Investigators
- Vivek Kr Mahato, BDS, Principal investigator, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479320
- Sponsor's protocol ID
- IRC/1078/017
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahato VK, Dongol A, Acharya P, Yadav AK, Subedi A, Jaisani MR. "Can Perioperative Intravenous Lidocaine Decrease Postoperative Pain After Oral and Maxillofacial Surgeries?": A Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Oct;23(5):1240-1247. doi: 10.1007/s12663-022-01831-1. Epub 2022 Dec 20.
PubMed 39376771
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03479320
- Acronym / sponsor ID
- IRC/1078/017
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: LidocaineLidocaine 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 |
| Placebo | Placebo comparator | Drug: PlaceboThey will receive the same volume of 0.9% of normal saline as calculated for the experimental group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocainePostoperative analgesic effects will be compared between lidocaine and normal saline group | Drug | Lidocaine group |
| PlaceboPostoperative anlagesic requirements will be calculated and compared with experimental group | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Total opioid consumption
Time frame: 24 hours
Time to first analgesic request
Time frame: 24 hours
Side effects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 39376771Mahato VK, Dongol A, Acharya P, Yadav AK, Subedi A, Jaisani MR. "Can Perioperative Intravenous Lidocaine Decrease Postoperative Pain After Oral and Maxillofacial Surgeries?": A Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Oct;23(5):1240-1247. doi: 10.1007/s12663-022-01831-1. Epub 2022 Dec 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Kr Mahato, BDS principal investigator
B.P. Koirala Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Numeric Rating Scale(NRS) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.