Lidocaine Jelly for Pain Control During Mohs Surgery

Hypothesis: Supplementing lidocaine/epinephrine injections with intralesional lidocaine jelly
will decrease the overall quantity of lidocaine/epinephrine injectable used, and will
decrease patients' self-reported pain/anxiety associated with needle sticks.

Objectives: To assess how using lidocaine jelly in Mohs surgery impacts 1) the overall
quantity of lidocaine/epinephrine injectable needed to maintain anesthesia, and 2) patients'
pain/anxiety associated with anesthesia injections.

Background:

Mohs micrographic surgery is a procedure that removes cancerous lesions of the skin in a
step-wise fashion. Patients are injected with local analgesia for tumor extirpation. The
tumor is removed and the tissue is sent for histopathology while the patient waits. Tissue
processing time can take up to 2 hours during which the effects of the local analgesia have
waned. Once the tissue has been process and examined, patients are brought back to the
surgical suite and either have another section of tissue removed (if the margins were
positive) or have the wound reconstructed (if the margins were negative). Lidocaine
Hydrochloride (Xylocaine) injection with Epinephrine is the traditionally method used to
maintain local anesthesia throughout the procedure. The FDA has declared a shortage of this
injectable Lidocaine/Epinephrine, stressing the need for a substitute drug. Additionally,
multiple needle sticks can be uncomfortable and anxiety provoking for patients. Needle sticks
on hypersensitive areas such as the nose can be particularly painful. Previous research has
demonstrated that a different form of anesthetic, a topical lidocaine jelly, is efficient in
prolonging anesthesia in Mohs surgery (Robins, 1991). No study has published the impact of
supplemental lidocaine jelly use on the overall quantity of injection needed, nor on patient
pain/anxiety associated with needle sticks.

Methods:

We will conduct a prospective, randomized trial of 250 patients receiving Mohs micrographic
surgery to lesions on the nose. Annually Mohs micrographic surgery is performed on
approximately 900 patients with 30% of these procedures being performed on lesions on the
nose. Patients receiving Mohs treatment for lesions on the nose will be randomly assigned to
one of two groups: (1) those whose wounds will be dressed with lidocaine jelly (treatment
group), and (2) those whose wounds will be dressed with surgical lubricant (control/placebo
group).

All patients will receive a pre-treatment baseline pain/anxiety survey followed by an initial
lidocaine injection. The amount of lidocaine/epinephrine injection each patient receives
throughout remaining stages of surgery will be recorded, as per the current workflow. All
patients will complete a second pain/anxiety survey immediately after numbing but prior to
the first stage of surgery.

After the first stage of surgery, either lidocaine jelly or surgical lubricant will be
applied to the wound followed by a pressure bandage as per standard practice. Dressing are
removed immediately prior to the next stage of surgery. After each subsequent stage of
surgery, an identical wound dressing will be placed on the operative site.

Immediately prior to each subsequent stage of surgery, we will assess patients' pain
sensation, and additional lidocaine/epinephrine will be injected if needed. After the
surgical site is re-anesthetized, vital signs will be recorded and the Pain/Anxiety survey
administered immediately prior to the first incision of that stage.

Inclusion criteria:

Patients having Mohs surgery on the nose who are able to consent to the study >18 years old

Exclusion criteria:

unable to consent for themselves known allergy to lidocaine Mohs surgery in locations other
than the nose