Skin Cancer FaceNCT07222241
Comparing Numbing Techniques in Mohs Micrographic Surgery
A study testing Nerve Block in people with Skin Cancer Face and Skin Cancer Scalp, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer Face, Skin Cancer Scalp
- What is being tested?
- Nerve Block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Skin Cancer Face, Skin Cancer Scalp
- Being tested
- Nerve Block, Placebo Nerve Block
- Keywords
- Mohs, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockOther
0.45% lidocaine with 1:200,000 epinephrine
Placebo Nerve BlockOther
Sterile normal saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo Nerve Block | Placebo comparator | Placebo regional nerve block with sterile normal saline plus local anesthetic infiltration of the tumor site. Receives: Other: Placebo Nerve Block |
| Regional Nerve Block | Experimental | Adjunct regional nerve block with lidocaine plus local anesthetic infiltration of the tumor site. Receives: Other: Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Pain
Pain rating reported by the patient using a Visual Analog Scale (0 = no pain; 10 = worst pain imaginable).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Stage 1 of Mohs micrographic surgery.
Patient Satisfaction
Score from a five-point Likert scale assessing patient satisfaction. Higher scores indicate greater satisfaction.
Measured: Assessed at the end of stage 1 of Mohs micrographic surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start27 Jan 2026
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Miller, MD, Principal investigator, Univerisity of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222241
- Sponsor's protocol ID
- UPCC 10625
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of Adjunct Nerve Blocks in Mohs Micrographic Surgery on the Face and Scalp
- ClinicalTrials.gov ID
- NCT07222241
- Acronym / sponsor ID
- UPCC 10625
- Conditions
- Skin Cancer Face, Skin Cancer Scalp
- Keywords
- Mohs, Nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Nerve Block | Placebo comparator | Other: Placebo Nerve BlockPlacebo regional nerve block with sterile normal saline plus local anesthetic infiltration of the tumor site. |
| Regional Nerve Block | Experimental | Other: Nerve BlockAdjunct regional nerve block with lidocaine plus local anesthetic infiltration of the tumor site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve Block0.45% lidocaine with 1:200,000 epinephrine | Other | Regional Nerve Block |
| Placebo Nerve BlockSterile normal saline | Other | Placebo Nerve Block |
Primary outcome
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).
5 secondary outcomes
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.
Needle Sticks
Time frame: During local infiltration.
Anesthetic Volume
Time frame: From the administration of the first nerve block to the end of stage 1.
Rescue Anesthesia
Time frame: Stage 1 of Mohs micrographic surgery.
Patient Satisfaction
Time frame: Assessed at the end of stage 1 of Mohs micrographic surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Miller, MD principal investigator
Univerisity of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Block in people with Skin Cancer Face and Skin Cancer Scalp, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.