Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

NCT ID: NCT02647892

Last Updated: 2023-08-21

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-08

Study Completion Date

2021-11-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

10 mg/mL lidocaine; Frequency: 1

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

local anesthesia

Arm B

9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

local anesthesia

sodium bicarbonate

Intervention Type DRUG

additional drug added to lidocaine

Arm C

7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

local anesthesia

sodium bicarbonate

Intervention Type DRUG

additional drug added to lidocaine

Arm D

5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

local anesthesia

sodium bicarbonate

Intervention Type DRUG

additional drug added to lidocaine

Interventions

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lidocaine

local anesthesia

Intervention Type DRUG

sodium bicarbonate

additional drug added to lidocaine

Intervention Type DRUG

Other Intervention Names

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xylocaine

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 25991379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2240750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9672449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1430977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8136599 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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0787-15-EP

Identifier Type: -

Identifier Source: org_study_id

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