NCT02620683

Brief Summary

Anecdotal reports suggest buffering lidocaine with epinephrine just before intraoral injection reduces time of onset, results in a deeper anesthetic effect, without the "sting" with injection from a low pH. Additional data are needed to establish clinical important outcomes such as the peak blood level of lidocaine as compared to the non-buffered drug combination. Clinical pilot studies are proposed as the start of a series of investigations to support or modify the use of the buffered anesthetic for intraoral procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

December 1, 2015

Results QC Date

September 25, 2017

Last Update Submit

December 22, 2017

Conditions

Blood Levels of Buffered vs Non-buffered LidocaineAnesthetics, Local

Keywords

lidocaine, jaw

Outcome Measures

Primary Outcomes (1)

  • Lidocaine Blood Levels 30 Minutes Post Injection

    Lidocaine blood levels were obtained 30 minutes post injection micro g/L The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon rank sum tests with Proc NPAR1WAY (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.

    30 minutes post injection

Secondary Outcomes (3)

  • Pain Intensity Scores

    Immediately after lidocaine injection

  • Number of Minutes to Anesthesia Symptoms of Lower Lip

    Patient report of anesthesia symptom onset following injection

  • Topical Anesthesia Effect Contralateral Lower Lip

    At time of administration

Study Arms (2)

Buffered Lidocaine

ACTIVE COMPARATOR

In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels

Drug: Lidocaine

Non-buffered Lidocaine

ACTIVE COMPARATOR

In week One each subject would receive anesthetic to block the inferior alveolar and lingual N; Halstead or Gow-Gates techniques. No Buccal N. block. At least a week later injections would involve the alternate local anesthetic combination. Venous blood samples would be drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels

Drug: Lidocaine

Interventions

LidocaineDRUG

See above

Also known as: Xylocaine
Buffered LidocaineNon-buffered Lidocaine

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30 years
  • ASA I
  • Willingness to complete QOL instrument
  • Willingness to participate in two sessions

You may not qualify if:

  • Allergy to lidocaine class of anesthetic drugs
  • Local anesthetic drug use in past week
  • Current symptoms teeth or oral mucosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

Related Publications (1)

  • Phero JA, Nelson B, Davis B, Dunlop N, Phillips C, Reside G, Tikunov AP, White RP Jr. Buffered Versus Non-Buffered Lidocaine With Epinephrine for Mandibular Nerve Block: Clinical Outcomes. J Oral Maxillofac Surg. 2017 Apr;75(4):688-693. doi: 10.1016/j.joms.2016.09.055. Epub 2016 Oct 8.

    PMID: 27815105RESULT

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr Raymond P. White Jr
Organization
University of North Carolina Chapel Hill
ray_white@unc.edu
919-537-3944

Study Officials

  • Raymond P White, Jr, DDS, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

January 23, 2018

Results First Posted

January 23, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)