Numbing methods for Mohs surgery on the face and scalp.
Randomized, Double-Blind, Placebo-Controlled Trial of Adjunct Nerve Blocks in Mohs Micrographic Surgery on the Face and Scalp
This test sees if adding a regional nerve block to the usual local numbing lowers pain and anxiety for adults having Mohs surgery on the face or scalp.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07222241 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, single-center trial of adults having Mohs micrographic surgery for cancers on the face or scalp. Participants are randomized to receive either a placebo regional nerve block (saline) or an active regional nerve block with lidocaine, and all patients receive standard local infiltration with lidocaine with epinephrine. Pain and anxiety are measured using validated 0–10 visual analog scales at several perioperative time points, and outcome assessors are blinded to group assignment. The study also tracks perioperative outcomes related to surgical efficiency and analgesic use to determine the practical effects of the nerve block.
Who should consider this trial
Good fit: Adults (age ≥18) scheduled for Mohs micrographic surgery for face or scalp skin cancers who meet the size/location criteria, can complete English patient-reported measures, and have no contraindication to lidocaine/epinephrine are ideal candidates.
Not a fit: Patients with known allergy to lidocaine or epinephrine, chronic opioid use or pain disorders, scar or infection at the injection site, inability to complete assessments, concurrent multisite Mohs, or who are pregnant or breastfeeding are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, adding a regional nerve block could reduce pain and anxiety during and immediately after Mohs surgery, improving patient comfort and potentially lowering additional pain medication needs.
How similar studies have performed: Regional nerve blocks have shown pain-reducing benefits in other outpatient facial and dermatologic procedures, but randomized evidence specifically in Mohs surgery is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Philadelphia, Pennsylvania
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Miller, MD — Univerisity of Pennsylvania
- Study coordinator: Kaiyu Ma Clinical research regulatory specialist, PhD
- Email: makaiyu@pennmedicine.upenn.edu
- Phone: 215-662-2123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.