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
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 29, 2025
CompletedStudy Start
First participant enrolled
January 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
January 29, 2026
January 1, 2026
6 months
October 22, 2025
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Anxiety
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
During local infiltration.
Anesthetic Volume
From the administration of the first nerve block to the end of stage 1.
Rescue Anesthesia
Stage 1 of Mohs micrographic surgery.
Patient Satisfaction
Assessed at the end of stage 1 of Mohs micrographic surgery.
Study Arms (2)
Placebo Nerve Block
PLACEBO COMPARATORPlacebo regional nerve block with sterile normal saline plus local anesthetic infiltration of the tumor site.
Regional Nerve Block
EXPERIMENTALAdjunct regional nerve block with lidocaine plus local anesthetic infiltration of the tumor site.
Interventions
Eligibility Criteria
You may qualify if:
- 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 lip, nose, or eyelid.
- Ability to complete patient reported outcome measures in English.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Miller, MD
Univerisity of Pennsylvania
Central Study Contacts
Kaiyu Ma Clinical research regulatory specialist, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2025
First Posted
October 29, 2025
Study Start
January 27, 2026
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After publication of the main study findings and for up to 5 years thereafter
- 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.
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.