Trial Outcomes & Findings for Clinical Outcomes of Buffered vs. Non-Buffered Lidocaine (NCT NCT02620683)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

30 minutes post injection

Results posted on

2018-01-23

Participant Flow

Beginning in December 2015 23 subjects recruited for study conducted in the surgery clinic at UNC School of Dentistry

No enrolled subjects excluded.

Participant milestones

Participant milestones
Measure	Buffered Lidocaine, Then Non-buffered Lidocaine At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.	Non-buffered Lidocaine, Then Buffererd Lidocaine At Visit 1 each subject received Non-Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Buffered Lidocaine in the same fashion at Visit 2.
First Intervention (Visit 1) STARTED	12	11
First Intervention (Visit 1) COMPLETED	12	11
First Intervention (Visit 1) NOT COMPLETED	0	0
Washout (2 Weeks) STARTED	12	11
Washout (2 Weeks) COMPLETED	12	11
Washout (2 Weeks) NOT COMPLETED	0	0
Second Intervention (Visit 2) STARTED	12	11
Second Intervention (Visit 2) COMPLETED	12	11
Second Intervention (Visit 2) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Outcomes of Buffered vs. Non-Buffered Lidocaine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=23 Participants Subjects who were randomized to receive either Buffered or Non-Buffered Lidocaine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	21 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Buffered Lidocaine and Non-Buffered Lidocaine n=23 Participants At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
Lidocaine Blood Levels 30 Minutes Post Injection buffered lidocaine	7.9 ug/L Standard Deviation 16.2
Lidocaine Blood Levels 30 Minutes Post Injection non-buffered lidocaine	15.8 ug/L Standard Deviation 16.2

SECONDARY outcome

Timeframe: Immediately after lidocaine injection

Patients reported pain level immediately after injection of lidocaine via a Likert type scale where 1 = No Pain and 10 = Worst Pain Imaginable. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered was performed.

Outcome measures

Outcome measures
Measure	Buffered Lidocaine and Non-Buffered Lidocaine n=23 Participants At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
Pain Intensity Scores buffered lidocaine	2.6 units on a scale Standard Deviation 1.56
Pain Intensity Scores non-buffered lidocaine	3.0 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Patient report of anesthesia symptom onset following injection

Patients were instructed to record the time when they experienced the initial indication of anesthesia signs in the lower lip. This was reported as the number of minutes following nerve block injection. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered was performed.

Outcome measures

Outcome measures
Measure	Buffered Lidocaine and Non-Buffered Lidocaine n=23 Participants At Visit 1 each subject received Buffered Lidocaine anesthetic to block the inferior alveolar and lingual N; using Halstead or Gow-Gates techniques. No Buccal N. block. Venous blood samples were drawn from the antecubital fossa 30min post oral injection and assayed for blood lidocaine levels. Following a 2-week washout, subjects received Non-buffered Lidocaine in the same fashion at Visit 2.
Number of Minutes to Anesthesia Symptoms of Lower Lip buffered lidocaine	10.2 minutes Standard Deviation 16.1
Number of Minutes to Anesthesia Symptoms of Lower Lip non-buffered lidocaine	13.7 minutes Standard Deviation 16.1

SECONDARY outcome

Timeframe: At time of administration

Population: Unable to administer in this fashion because Lidocaine would not remain on lip surface therefore data were not collected

Investigator will administer 5-6 drops of the lidocaine to the contralateral lower lip and immediately ask if signs of numbness are present on the lip. Patients reported presence of numbness lower lip-Yes or No

Outcome measures

Outcome data not reported

Adverse Events

Buffered Lidicaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-bufered Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Raymond P. White Jr

University of North Carolina Chapel Hill

Phone: 919-537-3944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place