Trial · NCT01981772
Efficacy of Buffered Lidocaine in Patients With Facial Swelling
NCT01981772, Not applicable, Completed, Ohio State University; results first posted 2020-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Buffered Lidocaine in Patients With Facial Swelling. Trials, record NCT01981772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01981772
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Buffered Lidocaine in Patients With Facial Swelling
- NCT number
- NCT01981772
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 88 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Orofacial Swelling
- Interventions
- 4% lidocaine with 1:100,000 epinephrine, 4% buffered lidocaine with 1:100,000 epinephrine
- First posted
- 2013-11-13
- Last updated
- 2020-10-12
- Results first posted
- 2020-10-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | during incision/drainage on Day 0 | Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of "faint", "weak", and "mild pain". Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor "moderate". Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of "strong", "intense", and "maximum possible." |
| Secondary | Postoperative Satisfaction on a 100 mm Visual Analog Scale | immediately post-procedure on Day 0 | Patients will rate their level of satisfaction with the incision and drainage procedure using a visual analog scale. The scale ranges from "not satisfied," to "somewhat satisfied," to "moderately satisfied," to "completely satisfied." Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm. Measurements along the scale were collected and analyzed by randomization test. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | during incision/drainage on Day 0 | units on a scale | MEAN | |
| SECONDARY | Postoperative Satisfaction on a 100 mm Visual Analog Scale | immediately post-procedure on Day 0 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | Buffered Lidocaine | 69.3 | Standard Deviation 60.1 | units on a scale | |
| Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale | Nonbuffered Lidocaine | 59.2 | Standard Deviation 50.5 | units on a scale | |
| Postoperative Satisfaction on a 100 mm Visual Analog Scale | Buffered Lidocaine | 92.7 | Standard Deviation 15.1 | units on a scale | |
| Postoperative Satisfaction on a 100 mm Visual Analog Scale | Nonbuffered Lidocaine | 89.5 | Standard Deviation 13.7 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buffered Lidocaine | 45 | |
| Overall Study | STARTED | Nonbuffered Lidocaine | 43 | |
| Overall Study | COMPLETED | Buffered Lidocaine | 45 | |
| Overall Study | COMPLETED | Nonbuffered Lidocaine | 43 | |
| Overall Study | NOT COMPLETED | Buffered Lidocaine | 0 | |
| Overall Study | NOT COMPLETED | Nonbuffered Lidocaine | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buffered Lidocaine | 0 | 45 |
| Total, all-cause mortality | Nonbuffered Lidocaine | 0 | 43 |
| Total, other adverse events | Buffered Lidocaine | 0 | 45 |
| Total, other adverse events | Nonbuffered Lidocaine | 0 | 43 |
| Total, serious adverse events | Buffered Lidocaine | 0 | 45 |
| Total, serious adverse events | Nonbuffered Lidocaine | 0 | 43 |
Source ClinicalTrials.gov
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buffered Lidocaine vs Nonbuffered Lidocaine: deaths from any cause | Trial comparisons |
| Buffered Lidocaine vs Nonbuffered Lidocaine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01981772
GET https://conductscience.org/api/trials/v1/NCT01981772/papers?page=2