Orofacial SwellingNCT01981772

Efficacy of Buffered Lidocaine in Patients With Facial Swelling

A study testing 4% lidocaine with 1:100,000 epinephrine and 4% buffered lidocaine with 1:100,000 epinephrine in people with Orofacial Swelling, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Orofacial Swelling
What is being tested?: 4% lidocaine with 1:100,000 epinephrine and 4% buffered lidocaine with 1:100,000 epinephrine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older
in good health (ASA classification I or II)
able to give informed consent
necrotic tooth with associated facial swelling

Who cannot join

allergies to local anesthetics or sulfites
history of significant medical problems (ASA classification III or greater)
pregnancy
inability to give informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University College of Dentistry
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling.

The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.

Read the detailed description

Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.

Conditions: Orofacial Swelling
Being tested: 4% lidocaine with 1:100,000 epinephrine, 4% buffered lidocaine with 1:100,000 epinephrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4% lidocaine with 1:100,000 epinephrineDrug
see arm/group description
4% buffered lidocaine with 1:100,000 epinephrineDrug
see arm/group description

Study groups in NCT01981772
Study group	Role	What they receive
buffered lidocaine	Experimental	administration of 4% buffered lidocaine with 1:100,000 epinephrine Receives: Drug: 4% buffered lidocaine with 1:100,000 epinephrine
nonbuffered lidocaine	Active comparator	administration of 4% lidocaine with 1:100,000 epinephrine Receives: Drug: 4% lidocaine with 1:100,000 epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
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."
Measured: during incision/drainage on Day 0

Secondary outcomes (1)

Postoperative Satisfaction on a 100 mm Visual Analog Scale
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.
Measured: immediately post-procedure on Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jun 2014

First posted13 Nov 2013 (estimated)
Study startMar 2013
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Orofacial SwellingStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01981772
Sponsor's protocol ID: 2012H0437
Status last verified: Oct 2020
First submitted: 31 Jul 2013
Last updated: 12 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Adhikari S, Blaivas M, Lander L. Comparison of bedside ultrasound and panorex radiography in the diagnosis of a dental abscess in the ED. Am J Emerg Med. 2011 Sep;29(7):790-5. doi: 10.1016/j.ajem.2010.03.005. Epub 2010 May 1.
PubMed 20825898
Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
PubMed 10339680
Strichartz GR. Novel ideas of local anaesthetic actions on various ion channels to ameliorate postoperative pain. Br J Anaesth. 2008 Jul;101(1):45-7. doi: 10.1093/bja/aen101. Epub 2008 May 16.
PubMed 18487246
Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.
PubMed 3863874
Isett J, Reader A, Gallatin E, Beck M, Padgett D. Effect of an intraosseous injection of depo-medrol on pulpal concentrations of PGE2 and IL-8 in untreated irreversible pulpitis. J Endod. 2003 Apr;29(4):268-71. doi: 10.1097/00004770-200304000-00010.
PubMed 12701778
Wells JE, Bingham V, Rowland KC, Hatton J. Expression of Nav1.9 channels in human dental pulp and trigeminal ganglion. J Endod. 2007 Oct;33(10):1172-6. doi: 10.1016/j.joen.2007.05.023. Epub 2007 Aug 27.
PubMed 17889684
Luo S, Perry GM, Levinson SR, Henry MA. Nav1.7 expression is increased in painful human dental pulp. Mol Pain. 2008 Apr 21;4:16. doi: 10.1186/1744-8069-4-16.
PubMed 18426592
Warren CA, Mok L, Gordon S, Fouad AF, Gold MS. Quantification of neural protein in extirpated tooth pulp. J Endod. 2008 Jan;34(1):7-10. doi: 10.1016/j.joen.2007.09.014. Epub 2007 Nov 26.
PubMed 18155483
Owatz CB, Khan AA, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. The incidence of mechanical allodynia in patients with irreversible pulpitis. J Endod. 2007 May;33(5):552-6. doi: 10.1016/j.joen.2007.01.023. Epub 2007 Mar 6.
PubMed 17437870
Modaresi J, Dianat O, Soluti A. Effect of pulp inflammation on nerve impulse quality with or without anesthesia. J Endod. 2008 Apr;34(4):438-41. doi: 10.1016/j.joen.2008.01.014. Epub 2008 Mar 4.
PubMed 18358891
Roy ML, Narahashi T. Differential properties of tetrodotoxin-sensitive and tetrodotoxin-resistant sodium channels in rat dorsal root ganglion neurons. J Neurosci. 1992 Jun;12(6):2104-11. doi: 10.1523/JNEUROSCI.12-06-02104.1992.
PubMed 1318956
Bartfield JM, Homer PJ, Ford DT, Sternklar P. Buffered lidocaine as a local anesthetic: an investigation of shelf life. Ann Emerg Med. 1992 Jan;21(1):16-9. doi: 10.1016/s0196-0644(05)82230-9.
PubMed 1539881
Zahl K, Jordan A, McGroarty J, Sorensen B, Gotta AW. Peribulbar anesthesia. Effect of bicarbonate on mixtures of lidocaine, bupivacaine, and hyaluronidase with or without epinephrine. Ophthalmology. 1991 Feb;98(2):239-42. doi: 10.1016/s0161-6420(91)32311-x.
PubMed 2008283
Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.
PubMed 11020760
Richtsmeier AJ, Hatcher JW. Buffered lidocaine for skin infiltration prior to hemodialysis. J Pain Symptom Manage. 1995 Apr;10(3):198-203. doi: 10.1016/0885-3924(94)00124-4.
PubMed 7629414

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling.
ClinicalTrials.gov ID: NCT01981772
Acronym / sponsor ID: 2012H0437
Conditions: Orofacial Swelling
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: Mar 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 13 Nov 2013 (estimated)
Results: Posted 12 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
buffered lidocaine	Experimental	Drug: 4% buffered lidocaine with 1:100,000 epinephrineadministration of 4% buffered lidocaine with 1:100,000 epinephrine
nonbuffered lidocaine	Active comparator	Drug: 4% lidocaine with 1:100,000 epinephrineadministration of 4% lidocaine with 1:100,000 epinephrine

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years or older
in good health (ASA classification I or II)
able to give informed consent
necrotic tooth with associated facial swelling

Key exclusion criteria (4 listed)

allergies to local anesthetics or sulfites
history of significant medical problems (ASA classification III or greater)
pregnancy
inability to give informed consent

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
4% lidocaine with 1:100,000 epinephrinesee arm/group description	Drug	nonbuffered lidocaine
4% buffered lidocaine with 1:100,000 epinephrinesee arm/group description	Drug	buffered lidocaine

Primary outcome

Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
Time frame: 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."

1 secondary outcome

Postoperative Satisfaction on a 100 mm Visual Analog Scale
Time frame: immediately post-procedure on Day 0

Results and safety

Results posted to the registry on 12 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buffered Lidocaine	45	45
Nonbuffered Lidocaine	43	43

Primary outcome: Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale

Time frame: during incision/drainage on Day 0. Mean (Standard Deviation). Unit: units on a scale

Measure	Buffered Lidocaine n = 45	Nonbuffered Lidocaine n = 43
Value	69.3 (60.1)	59.2 (50.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Monitored and assessed during procedure on Day 0. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buffered Lidocaine	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Nonbuffered Lidocaine	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20825898Adhikari S, Blaivas M, Lander L. Comparison of bedside ultrasound and panorex radiography in the diagnosis of a dental abscess in the ED. Am J Emerg Med. 2011 Sep;29(7):790-5. doi: 10.1016/j.ajem.2010.03.005. Epub 2010 May 1.
Background: PubMed 10339680Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
Background: PubMed 18487246Strichartz GR. Novel ideas of local anaesthetic actions on various ion channels to ameliorate postoperative pain. Br J Anaesth. 2008 Jul;101(1):45-7. doi: 10.1093/bja/aen101. Epub 2008 May 16.
Background: PubMed 3863874Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.
Background: PubMed 12701778Isett J, Reader A, Gallatin E, Beck M, Padgett D. Effect of an intraosseous injection of depo-medrol on pulpal concentrations of PGE2 and IL-8 in untreated irreversible pulpitis. J Endod. 2003 Apr;29(4):268-71. doi: 10.1097/00004770-200304000-00010.
Background: PubMed 17889684Wells JE, Bingham V, Rowland KC, Hatton J. Expression of Nav1.9 channels in human dental pulp and trigeminal ganglion. J Endod. 2007 Oct;33(10):1172-6. doi: 10.1016/j.joen.2007.05.023. Epub 2007 Aug 27.
Background: PubMed 18426592Luo S, Perry GM, Levinson SR, Henry MA. Nav1.7 expression is increased in painful human dental pulp. Mol Pain. 2008 Apr 21;4:16. doi: 10.1186/1744-8069-4-16.
Background: PubMed 18155483Warren CA, Mok L, Gordon S, Fouad AF, Gold MS. Quantification of neural protein in extirpated tooth pulp. J Endod. 2008 Jan;34(1):7-10. doi: 10.1016/j.joen.2007.09.014. Epub 2007 Nov 26.
Background: PubMed 17437870Owatz CB, Khan AA, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. The incidence of mechanical allodynia in patients with irreversible pulpitis. J Endod. 2007 May;33(5):552-6. doi: 10.1016/j.joen.2007.01.023. Epub 2007 Mar 6.
Background: PubMed 18358891Modaresi J, Dianat O, Soluti A. Effect of pulp inflammation on nerve impulse quality with or without anesthesia. J Endod. 2008 Apr;34(4):438-41. doi: 10.1016/j.joen.2008.01.014. Epub 2008 Mar 4.
Background: PubMed 1318956Roy ML, Narahashi T. Differential properties of tetrodotoxin-sensitive and tetrodotoxin-resistant sodium channels in rat dorsal root ganglion neurons. J Neurosci. 1992 Jun;12(6):2104-11. doi: 10.1523/JNEUROSCI.12-06-02104.1992.
Background: PubMed 1539881Bartfield JM, Homer PJ, Ford DT, Sternklar P. Buffered lidocaine as a local anesthetic: an investigation of shelf life. Ann Emerg Med. 1992 Jan;21(1):16-9. doi: 10.1016/s0196-0644(05)82230-9.
Individual participant dataSharing planned: No

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.

Melissa Drum, DDS, MS principal investigator

The Ohio State University College of Dentistry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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 12 Oct 2020. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale (time frame: during incision/drainage on Day 0). 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 NCT01981772, which also lists 25 linked publications.

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 12 Oct 2020.