Comparing Numbing Techniques in Mohs Micrographic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer Face; Skin Cancer Scalp
• Intervention / Treatment: Other: Placebo Nerve Block; Other: Nerve Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaiyu Ma Clinical research regulatory specialist, PhD; Phone Number: 215-662-2123; Email: makaiyu@pennmedicine.upenn.edu
• Study Contact Backup: Name: Christopher Richter, BS; Email: christopher.richter1@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Perelman Center for Advanced Medicine
      • Contact: Kaiyu Ma Clinical research regulatory specialist, PhD; Phone Number: 215-662-2123; Email: makaiyu@pennmedicine.upenn.edu
      • Contact: Christopher Richter Research Fellow; Email: christopher.richter1@pennmedicine.upenn.edu
      • Principal Investigator: Christopher Miller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Nerve Block; Placebo regional nerve block with sterile normal saline plus local anesthetic infiltration of the tumor site.	Other: Placebo Nerve Block; Sterile normal saline
Experimental: Regional Nerve Block; Adjunct regional nerve block with lidocaine plus local anesthetic infiltration of the tumor site.	Other: Nerve Block; 0.45% lidocaine with 1:200,000 epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Pain	Pain rating reported by the patient using a Visual Analog Scale (0 = no pain; 10 = worst pain imaginable).	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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.	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.
Needle Sticks	Number of needle sticks needed during local infiltration to achieve complete anesthesia. Does not include punctures used to assess numbness.	During local infiltration.
Anesthetic Volume	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.	From the administration of the first nerve block to the end of stage 1.
Rescue Anesthesia	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.	Stage 1 of Mohs micrographic surgery.
Patient Satisfaction	Score from a five-point Likert scale assessing patient satisfaction. Higher scores indicate greater satisfaction.	Assessed at the end of stage 1 of Mohs micrographic surgery.

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Christopher Miller, MD, Univerisity of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 22, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nerve block; Mohs
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Anesthesia and Analgesia; Neurosurgical Procedures; Anesthesia, Conduction; Anesthesia; Denervation; Nerve Block
• Other Study ID Numbers: UPCC 10625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (including clinical assessments) that underlie the results reported in this study will be made available to qualified researchers upon reasonable request. Data will be accessible after publication of the main study findings and for up to 5 years thereafter. Requests should be submitted in writing to the Principal Investigator, and access will be granted following review and approval by the University of Pennsylvania IRB and data use agreements as required.
• IPD Sharing Time Frame: After publication of the main study findings and for up to 5 years thereafter
• IPD Sharing Access Criteria: Requests should be submitted in writing to the Principal Investigator, and access will be granted following review and approval by the University of Pennsylvania IRB and data use agreements as required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes