UPCC 10625 Randomized, Double-Blind, Controlled Trial of Adjunct Nerve Blocks in Mohs Micrographic Surgery on the Face and Scalp

Study on Pain and Anxiety Reduction in Mohs Surgery with Nerve Blocks

Enrolling By Invitation
18 years or above
All
Phase N/A
150 participants needed
1 Location

Brief description of study

This study seeks to determine whether adjunct regional nerve blocks reduce pain and anxiety in adult patients undergoing Mohs micrographic surgery for face and scalp skin cancers. Participants will be randomized to one of two arms: (1) placebo regional nerve block with sterile normal saline or (2) adjunct regional nerve block with lidocaine. All patients receive local infiltration with lidocaine for complete anesthesia.

Detailed description of study

This study is a prospective, randomized, single-center clinical trial involving adult patients undergoing Mohs micrographic surgery for cutaneous malignancy on the face and scalp. Patients will be randomized into one of two study arms:

  1. Placebo Nerve Block Group: Placebo regional nerve block with sterile normal saline plus standard local infiltration with 0.45% lidocaine with 1:200,000 epinephrine.
  2. Experimental Nerve Block Group: Regional nerve block with 0.45% lidocaine with 1:200,000 epinephrine plus standard local infiltration with 0.45% lidocaine with 1:200,000 epinephrine.

Pain scores and other perioperative outcomes will be measured to assess the impact of these anesthetic techniques on patient experience, surgical efficiency, and analgesic efficacy. Pain will be assessed using a validated 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain imaginable. Patients will rate their pain at three time points on a printed VAS scale: (T1) after nerve block, (T2) immediately after completion of local infiltration but before surgical excision, and (T3) at the end of stage 1 of Mohs micrographic surgery. Anxiety will be assessed using a validated 0-10 VAS (0 = no anxiety, 10 = worst anxiety imaginable) at the same three time points (T1, T2, and T3). Anxiety will also be assessed preoperatively (T0). Patients will be instructed on the use of these scales prior to surgery, and outcome assessors blinded to allocation will record responses verbatim at the specified intervals. Subjects will be randomized in a 1:1 ratio to either of the study arms. Randomization will be performed using a computer-generated sequence. Allocation concealment will be maintained through sealed opaque envelopes or electronic assignment by personnel not involved in outcome assessment. The study is double-blind; neither the patient nor the clinical staff assessing outcomes will be aware of the group allocation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Skin Cancer Face, Skin Cancer Scalp
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Age ≥18 years.
  • Scheduled to undergo MMS.
  • Lesions on the face or scalp, defined as the region superior to the mandibular margin anteriorly, superior to the external occipital protuberance posteriorly, and superior to the mastoid processes laterally.
  • Tumor diameter plus anticipated stage 1 MMS margin ≥2 cm in diameter OR any tumor on the ear, lip, nose, or eyelid.
  • Ability to complete patient reported outcome measures in English.

Exclusion Criteria:

  • Known allergy or contraindication to lidocaine or epinephrine.
  • Chronic opioid use or pre existing pain disorders that may interfere with pain reporting.
  • Presence of scar tissue at the anatomic site of local infiltration or nerve block that may alter anesthetic penetration.
  • Concurrent multi site Mohs procedure.
  • Signs of skin and soft tissue infection at the anatomic site of local infiltration or nerve block.
  • Inability to understand or complete pain and satisfaction assessments.
  • Pregnant or breastfeeding.
  • Use of sedatives or anxiolytics prior to the procedure.

This study investigates whether additional regional nerve blocks can reduce pain and anxiety in adults undergoing Mohs micrographic surgery for skin cancers on the face and scalp. Participants will be randomly assigned to one of two study arms: one receiving a placebo nerve block with sterile saline and the other receiving an adjunct nerve block with lidocaine. Both groups will receive standard local anesthesia with lidocaine.

Participants will undergo a series of procedures to assess pain and anxiety levels. Pain will be measured using a Visual Analog Scale (VAS) at three different times: after the nerve block, after local infiltration but before surgery, and at the end of the first stage of surgery. Anxiety will also be assessed at these times and additionally before surgery. The study is double-blind, meaning neither the patients nor the outcome assessors will know which treatment the participants receive. This ensures unbiased results.

  • Who can participate: Adults aged 18 and older scheduled for Mohs micrographic surgery on the face or scalp can participate. Key eligibility includes having a lesion with a certain size or location, like on the lip, nose, or eyelid, and being able to complete outcome measures in English.
  • Study details: Participants will be randomized to receive either a placebo nerve block or an active nerve block with lidocaine, in addition to standard local anesthesia. Pain and anxiety levels will be recorded using scales before and after surgery to evaluate the effectiveness of the nerve blocks.
Updated on 29 May 2026. Study ID: 25-1590
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