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NCT02647892 Clinical Trial

Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

Local Anesthesia Clinical Trial

Official title:
Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02647892
Other study ID # 0787-15-EP
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 8, 2016
Est. completion date November 5, 2021

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.

Description:

Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.

Recruitment information / eligibility
Status Terminated
Enrollment 70
Est. completion date November 5, 2021
Est. primary completion date November 5, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 100 Years
Eligibility Inclusion Criteria: - adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology Exclusion Criteria: - Patients requiring sedation - Patients with altered mental status - Children - Patients allergic to lidocaine or sodium bicarbonate

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lidocaine
local anesthesia
• sodium bicarbonate
additional drug added to lidocaine

Locations
Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

Machin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Injection pain numeric pain scale 6 months
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