Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
NCT ID: NCT02647892
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
70 participants
INTERVENTIONAL
2016-01-08
2021-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A
10 mg/mL lidocaine; Frequency: 1
lidocaine
local anesthesia
Arm B
9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1
lidocaine
local anesthesia
sodium bicarbonate
additional drug added to lidocaine
Arm C
7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1
lidocaine
local anesthesia
sodium bicarbonate
additional drug added to lidocaine
Arm D
5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1
lidocaine
local anesthesia
sodium bicarbonate
additional drug added to lidocaine
Interventions
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lidocaine
local anesthesia
sodium bicarbonate
additional drug added to lidocaine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with altered mental status
* Children
* Patients allergic to lidocaine or sodium bicarbonate
19 Years
100 Years
ALL
No
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Joseph McBride, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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References
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Skarsvag TI, Wago KJ, Tangen LF, Lundbom JS, Hjelseng T, Ballo S, Finsen V. Does adjusting the pH of lidocaine reduce pain during injection? J Plast Surg Hand Surg. 2015 Oct;49(5):265-267. doi: 10.3109/2000656X.2015.1047780. Epub 2015 May 19.
Bartfield JM, Gennis P, Barbera J, Breuer B, Gallagher EJ. Buffered versus plain lidocaine as a local anesthetic for simple laceration repair. Ann Emerg Med. 1990 Dec;19(12):1387-9. doi: 10.1016/s0196-0644(05)82603-4.
Colaric KB, Overton DT, Moore K. Pain reduction in lidocaine administration through buffering and warming. Am J Emerg Med. 1998 Jul;16(4):353-6. doi: 10.1016/s0735-6757(98)90126-7.
Orlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5. doi: 10.1016/0736-4679(92)90269-y.
Matsumoto AH, Reifsnyder AC, Hartwell GD, Angle JF, Selby JB Jr, Tegtmeyer CJ. Reducing the discomfort of lidocaine administration through pH buffering. J Vasc Interv Radiol. 1994 Jan-Feb;5(1):171-5. doi: 10.1016/s1051-0443(94)71478-0.
Machin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.
Other Identifiers
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0787-15-EP
Identifier Type: -
Identifier Source: org_study_id
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