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NCT Number: NCT07222241

Comparing Numbing Techniques in Mohs Micrographic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Christopher Miller, MD

PRINCIPAL_INVESTIGATOR

Christopher Richter Research Fellow

CONTACT

[email protected]

Kaiyu Ma Clinical research regulatory specialist, PhD

CONTACT

[email protected]

215-662-2123

About this 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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nerve Block

Other

0.45% lidocaine with 1:200,000 epinephrine

Placebo Nerve Block

Other

Sterile normal saline

Primary outcomes

  1. Intraoperative Pain

    Time frame: T1: After nerve block; T2: Immediately after completion of local infiltration but before surgical excision; T3: At the end of stage 1 of Mohs micrographic surgery.

    Pain rating reported by the patient using a Visual Analog Scale (0 = no pain; 10 = worst pain imaginable).

Secondary outcomes

  1. Anxiety

    Time frame: T0: Preoperative; T1: After nerve block; T2: Immediately after completion of local infiltration but before surgical excision; T3: At the end of stage 1 of Mohs micrographic surgery.

    Anxiety rating reported by the patient using a Visual Analog Scale (0 = no anxiety; 10 = worst anxiety imaginable). Exploratory sub-endpoints will investigate the relationship between patient anxiety and pain scales.

  2. Needle Sticks

    Time frame: During local infiltration.

    Number of needle sticks needed during local infiltration to achieve complete anesthesia. Does not include punctures used to assess numbness.

  3. Anesthetic Volume

    Time frame: From the administration of the first nerve block to the end of stage 1.

    Sum of all injected volumes (blocks + infiltration + preventative + rescue). Exploratory sub-endpoints will investigate local infiltration-only volume to estimate sparing effect of nerve blocks.

  4. Rescue Anesthesia

    Time frame: Stage 1 of Mohs micrographic surgery.

    Proportion of participants receiving ≥1 rescue infiltration after anesthesia is complete and before stage-1 end. Exploratory sub-endpoint to investigate the number of rescue events during stage 1.

  5. Patient Satisfaction

    Time frame: Assessed at the end of stage 1 of Mohs micrographic surgery.

    Score from a five-point Likert scale assessing patient satisfaction. Higher scores indicate greater satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Richter, BS

CONTACT

[email protected]

Kaiyu Ma Clinical research regulatory specialist, PhD

CONTACT

[email protected]

215-662-2123

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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