Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 5, 2021

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Arm A
    • 10 mg/mL lidocaine; Frequency: 1
  • Active Comparator: Arm B
    • 9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1
  • Active Comparator: Arm C
    • 7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1
  • Active Comparator: Arm D
    • 5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1

Clinical Trial Outcome Measures

Primary Measures

  • Injection pain
    • Time Frame: 6 months
    • numeric pain scale

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nebraska
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph McBride, MD, Principal Investigator, University of Nebraska

References

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.

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