Efficacy of Buffered Lidocaine in Patients With Facial Swelling

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01981772
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Orofacial Swelling	Drug: 4% lidocaine with 1:100,000 epinephrine; Drug: 4% buffered lidocaine with 1:100,000 epinephrine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling.
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: buffered lidocaine administration of 4% buffered lidocaine with 1:100,000 epinephrine	Drug: 4% buffered lidocaine with 1:100,000 epinephrine; see arm/group description
Active Comparator: nonbuffered lidocaine administration of 4% lidocaine with 1:100,000 epinephrine	Drug: 4% lidocaine with 1:100,000 epinephrine; see arm/group description

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• in good health (ASA classification I or II)

• able to give informed consent

• necrotic tooth with associated facial swelling

Exclusion Criteria:

• allergies to local anesthetics or sulfites

• history of significant medical problems (ASA classification III or greater)

• pregnancy

• inability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Dentistry	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Melissa Drum, DDS, MS, The Ohio State University College of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ackerman WE 3rd, Ware TR, Juneja M. The air-liquid interface and the pH and PCO2 of alkalinized local anaesthetic solutions. Can J Anaesth. 1992 Apr;39(4):387-9.
• 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.
• 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.
• Benzon HT, Toleikis JR, Dixit P, Goodman I, Hill JA. Onset, intensity of blockade and somatosensory evoked potential changes of the lumbosacral dermatomes after epidural anesthesia with alkalinized lidocaine. Anesth Analg. 1993 Feb;76(2):328-32.
• Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31.
• Catchlove RF. The influence of CO 2 and pH on local anesthetic action. J Pharmacol Exp Ther. 1972 May;181(2):298-309.
• 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.
• Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9.
• Corah NL. Development of a dental anxiety scale. J Dent Res. 1969 Jul-Aug;48(4):596.
• DiFazio CA, Carron H, Grosslight KR, Moscicki JC, Bolding WR, Johns RA. Comparison of pH-adjusted lidocaine solutions for epidural anesthesia. Anesth Analg. 1986 Jul;65(7):760-4.
• Heft MW, Parker SR. An experimental basis for revising the graphic rating scale for pain. Pain. 1984 Jun;19(2):153-61.
• 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.
• 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.
• 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.
• Newton JT, Buck DJ. Anxiety and pain measures in dentistry: a guide to their quality and application. J Am Dent Assoc. 2000 Oct;131(10):1449-57.
• 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. Epub 2007 Mar 6.
• Richtsmeier AJ, Hatcher JW. Buffered lidocaine for skin infiltration prior to hemodialysis. J Pain Symptom Manage. 1995 Apr;10(3):198-203.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Epub 2007 Nov 26.
• 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. Epub 2007 Aug 27.
• Whitcomb M, Drum M, Reader A, Nusstein J, Beck M. A prospective, randomized, double-blind study of the anesthetic efficacy of sodium bicarbonate buffered 2% lidocaine with 1:100,000 epinephrine in inferior alveolar nerve blocks. Anesth Prog. 2010 Summer;57(2):59-66. doi: 10.2344/0003-3006-57.2.59.
• 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.

• Responsible Party: Melissa Drum, Associate Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT01981772
• Other Study ID Numbers: 2012H0437
• First Posted: Nov 13, 2013
• Last Update Posted: Oct 12, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate

Study Results

Participant Flow

Arm/Group Title	Buffered Lidocaine	Nonbuffered Lidocaine
Arm/Group Description	administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
Period Title: Overall Study
STARTED	45	43
COMPLETED	45	43
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Buffered Lidocaine	Nonbuffered Lidocaine	Total
Arm/Group Description	administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine	Total of all reporting groups
Overall Participants	45	43	88
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	45 100%	43 100%	88 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.8 (13.0)	36.3 (13.4)	36.55 (13.2)
Sex: Female, Male (Count of Participants)
Female	19 42.2%	19 44.2%	38 43.2%
Male	26 57.8%	24 55.8%	50 56.8%
Region of Enrollment (participants) [Number]
United States	45 100%	43 100%	88 100%

Outcome Measures

1. Primary Outcome

Title	Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
Description	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."
Time Frame	during incision/drainage on Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buffered Lidocaine	Nonbuffered Lidocaine
Arm/Group Description	administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
Measure Participants	45	43
Mean (Standard Deviation) [units on a scale]	69.3 (60.1)	59.2 (50.5)

2. Secondary Outcome

Title	Postoperative Satisfaction on a 100 mm Visual Analog Scale
Description	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.
Time Frame	immediately post-procedure on Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buffered Lidocaine	Nonbuffered Lidocaine
Arm/Group Description	administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
Measure Participants	45	43
Mean (Standard Deviation) [units on a scale]	92.7 (15.1)	89.5 (13.7)

Adverse Events

Time Frame	Monitored and assessed during procedure on Day 0
Arm/Group Title	Buffered Lidocaine		Nonbuffered Lidocaine
Arm/Group Description	administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine		administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
All Cause Mortality
	Buffered Lidocaine		Nonbuffered Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/43 (0%)
Serious Adverse Events
	Buffered Lidocaine		Nonbuffered Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Buffered Lidocaine		Nonbuffered Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.