James A Phero1, Blake Nelson2, Bobby Davis3, Natalie Dunlop3, Ceib Phillips4, Glenn Reside5, Andrew P Tikunov6, Raymond P White7. 1. Resident, Department of Oral and Maxillofacial Surgery, School of Dentistry, University of North Carolina, Chapel Hill, NC. 2. Former Dental Student, School of Dentistry, University of North Carolina, Chapel Hill, NC. 3. Dental Student, School of Dentistry, University of North Carolina, Chapel Hill, NC. 4. Professor, Department of Orthodontics, School of Dentistry, University of North Carolina, Chapel Hill, NC. 5. Clinical Associate Professor, Department of Oral and Maxillofacial Surgery, School of Dentistry, University of North Carolina, Chapel Hill, NC. 6. Research Associate, UNC/NCSU Joint Department of Biomedical Engineering, School of Dentistry, University of North Carolina, Chapel Hill, NC. 7. Dalton L. McMichael Distinguished Professor, Department of Oral and Maxillofacial Surgery, School of Dentistry, University of North Carolina, Chapel Hill, NC. Electronic address: ray_white@dentistry.unc.edu.
Abstract
PURPOSE: Outcomes for peak blood levels were assessed for buffered 2% lidocaine with 1:100,000 epinephrine compared with non-buffered 2% lidocaine with 1:100,000 epinephrine. PATIENTS AND METHODS: In this institutional review board-approved prospective, randomized, double-blinded, crossover trial, the clinical impact of buffered 2% lidocaine with 1:100,000 epinephrine (Anutra Medical, Research Triangle Park, Cary, NC) was compared with the non-buffered drug. Venous blood samples for lidocaine were obtained 30 minutes after a mandibular nerve block with 80 mg of the buffered or unbuffered drug. Two weeks later, the same subjects were tested with the alternate drug combinations. Subjects also reported on pain on injection with a 10-point Likert-type scale and time to lower lip numbness. The explanatory variable was the drug formulation. Outcome variables were subjects' peak blood lidocaine levels, subjective responses to pain on injection, and time to lower lip numbness. Serum lidocaine levels were analyzed with liquid chromatography-mass spectrometry. Statistical analyses were performed using Proc TTEST (SAS 9.3; SAS Institute, Cary, NC), with the crossover option for a 2-period crossover design, to analyze the normally distributed outcome for pain. For non-normally distributed outcomes of blood lidocaine levels and time to lower lip numbness, an assessment of treatment difference was performed using Wilcoxon rank-sum tests with Proc NPAR1WAY (SAS 9.3). Statistical significance was set at a P value less than .05 for all outcomes. RESULTS:Forty-eight percent of subjects were women, half were Caucasian, 22% were African American, and 13% were Asian. Median age was 21 years (interquartile range [IQR], 20-22 yr), and median body weight was 147 lb (IQR, 130-170 lb). Median blood levels (44 blood samples) at 30 minutes were 1.19 μg/L per kilogram of body weight. Mean blood level differences of lidocaine for each patient were significantly lower after nerve block with the buffered drug compared with the non-buffered agent (P < .01). Mean score for pain on injection for nerve block (n = 46 scores) was 3.3 (standard deviation, 0.9). Seventy-eight percent of subjects reported lower or the same pain scores with the buffered drug; 61% of subjects reported a shorter time to lower lip numbness with the buffered drug. CONCLUSIONS: Buffering 2% lidocaine with epinephrine can produce clinical outcomes favorable for subjects and clinicians without clinically detrimental peak blood lidocaine levels.
RCT Entities:
PURPOSE: Outcomes for peak blood levels were assessed for buffered 2% lidocaine with 1:100,000 epinephrine compared with non-buffered 2% lidocaine with 1:100,000 epinephrine. PATIENTS AND METHODS: In this institutional review board-approved prospective, randomized, double-blinded, crossover trial, the clinical impact of buffered 2% lidocaine with 1:100,000 epinephrine (Anutra Medical, Research Triangle Park, Cary, NC) was compared with the non-buffered drug. Venous blood samples for lidocaine were obtained 30 minutes after a mandibular nerve block with 80 mg of the buffered or unbuffered drug. Two weeks later, the same subjects were tested with the alternate drug combinations. Subjects also reported on pain on injection with a 10-point Likert-type scale and time to lower lip numbness. The explanatory variable was the drug formulation. Outcome variables were subjects' peak blood lidocaine levels, subjective responses to pain on injection, and time to lower lip numbness. Serum lidocaine levels were analyzed with liquid chromatography-mass spectrometry. Statistical analyses were performed using Proc TTEST (SAS 9.3; SAS Institute, Cary, NC), with the crossover option for a 2-period crossover design, to analyze the normally distributed outcome for pain. For non-normally distributed outcomes of blood lidocaine levels and time to lower lip numbness, an assessment of treatment difference was performed using Wilcoxon rank-sum tests with Proc NPAR1WAY (SAS 9.3). Statistical significance was set at a P value less than .05 for all outcomes. RESULTS: Forty-eight percent of subjects were women, half were Caucasian, 22% were African American, and 13% were Asian. Median age was 21 years (interquartile range [IQR], 20-22 yr), and median body weight was 147 lb (IQR, 130-170 lb). Median blood levels (44 blood samples) at 30 minutes were 1.19 μg/L per kilogram of body weight. Mean blood level differences of lidocaine for each patient were significantly lower after nerve block with the buffered drug compared with the non-buffered agent (P < .01). Mean score for pain on injection for nerve block (n = 46 scores) was 3.3 (standard deviation, 0.9). Seventy-eight percent of subjects reported lower or the same pain scores with the buffered drug; 61% of subjects reported a shorter time to lower lip numbness with the buffered drug. CONCLUSIONS: Buffering 2% lidocaine with epinephrine can produce clinical outcomes favorable for subjects and clinicians without clinically detrimental peak blood lidocaine levels.
Authors: Lukas B Seifert; Christopher Langhans; Yakub Berdan; Sophie Zorn; Michelle Klos; Constantin Landes; Robert Sader Journal: Oral Maxillofac Surg Date: 2022-05-20