NCT02647892

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

January 8, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

5.8 years

First QC Date

December 17, 2015

Last Update Submit

August 16, 2023

Conditions

Local Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Injection pain

    numeric pain scale

    6 months

Study Arms (4)

Arm A

ACTIVE COMPARATOR

10 mg/mL lidocaine; Frequency: 1

Drug: lidocaine

Arm B

ACTIVE COMPARATOR

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

Drug: lidocaineDrug: sodium bicarbonate

Arm C

ACTIVE COMPARATOR

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

Drug: lidocaineDrug: sodium bicarbonate

Arm D

ACTIVE COMPARATOR

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

Drug: lidocaineDrug: sodium bicarbonate

Interventions

lidocaineDRUG

local anesthesia

Also known as: xylocaine
Arm AArm BArm CArm D
sodium bicarbonateDRUG

additional drug added to lidocaine

Arm BArm CArm D

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology

You may not qualify if:

  • Patients requiring sedation
  • Patients with altered mental status
  • Children
  • Patients allergic to lidocaine or sodium bicarbonate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (6)

  • 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.

    PMID: 25991379BACKGROUND

  • 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.

    PMID: 2240750BACKGROUND

  • 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.

    PMID: 9672449BACKGROUND

  • 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.

    PMID: 1430977BACKGROUND

  • 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.

    PMID: 8136599BACKGROUND

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

    BACKGROUND

MeSH Terms

Interventions

LidocaineSodium Bicarbonate

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesBicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Joseph McBride, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

January 6, 2016

Study Start

January 8, 2016

Primary Completion

November 5, 2021

Study Completion

November 5, 2021

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)