ratio, in which each mL contained 9 mg of sodium chloride and 9 mg of benzyl alcohol.
Solution B (buffered): 5 mL of 8.4% sodium bicarbonate solution and 50 mL of 1% lidocaine and epinephrine in a 1:10 ratio.
Both solutions were kept at room temperature. One dermatologist, M.Z., determined the need for biopsies for each individual,
and the same physician then gave each patient subcutaneous
injections with a 31-gauge needle that contained 0.3 mL of
each solution in two discrete but comparable sites with regard
to pain fiber distribution (ie, the left and right cheeks) before
either a shave or a punch biopsy. The rate of injection was standardized
to the best of the physician's ability, the same injection
technique was used for each patient, and the same biopsy technique
was then used for both sites on each patient.
The buffered and unbuffered LAs were handed to the physician
in a blinded fashion by the same medical assistant who
prepared the solutions (ie, neither the physician nor the patients
were aware of the content of each solution or the order in
which they were administered). In order to ensure consistency,
the same number of patients received the buffered solution followed
by the unbuffered solution as received the unbuffered
solution first followed by the buffered solution. The sequence
was randomly assigned using a statistical program (IBM SPSS
Statistics 17.0.1) method to maximize internal validity. Between
15 and 20 seconds after the injection of the local anesthetic,
patients were asked to rate the pain of the needle insertion and
solution infiltration by using a visual analog scale (VAS) from 0
(no pain) to 10 (severe pain) in order to determine which injection
solution was the most comfortable (see Figure 1). Biopsies
were subsequently performed, and patients were immediately
asked to rate the pain experienced during the biopsy alone.
Only peak severity of pain upon injection and upon biopsy was recorded. The duration of pain was not recorded because providing
anesthesia during biopsy was deemed most relevant for
our study purposes.