Anesthesia (Numbing Medicine) in Mohs Surgery for Skin Cancer

Not Applicable

Not yet recruiting

• Conditions: Skin Cancer Face; Skin Cancer Scalp
• Interventions: Drug: Normal Saline; Drug: lidocaine 0.45%

• Registration Number: NCT07222241
• Lead Sponsor: University of Pennsylvania

Brief Summary

This study seeks to determine whether adjunct regional nerve blocks reduce pain and anxiety in adult patients undergoing Mohs micrographic surgery (MMS) for face and scalp skin cancers. Participants will be randomized to one of two arms: (1) sham adjunct regional nerve block with sterile normal saline and (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 MMS 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.

* 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 timepoints 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 MMS. Anxiety will be assessed using a validated 0-10 VAS (0 = no anxiety, 10 = worst anxiety imaginable) at the same three timepoints (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-blinded; neither the patient nor the clinical staff assessing outcomes will be aware of the group allocation.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Study First Posted: 2025-10-29
• Last Update Posted: 2025-10-29
• Study Start: 2025-12-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo regional nerve block	Normal Saline	Placebo regional nerve block with sterile normal saline plus local anesthetic infiltration of tumor site (control group)
Adjunct regional nerve block	lidocaine 0.45%	Adjunct regional nerve block with lidocaine plus local anesthetic infiltration of tumor site (study group).

Primary Outcome Measures

Name	Time	Method
Intraoperative pain at three time points (T1, T2, T3)	T1(Perioperative): After nerve block; T2 (Perioperative): Immediately after completion of local infiltration but before surgical excision; T3 (Perioperative): At the end of stage 1 of MMS	Pain rating reported using Visual Analog Scale (VAS) of 0 -10 by the patient as the total average pain experienced up to the time of query. VAS 0 = no pain and VAS 10 = worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Anxiety at four time points (T), T1, T2, T3)	T0 (Perioperative): Preoperative; T1 (Perioperative): After nerve block; T2 (Perioperative): Immediately after completion of local infiltration but before surgical excision; T3 (Perioperative): At the end of stage 1 of MMS	Anxiety rating with VAS 0-10 (0 = no anxiety, 10 = worst anxiety imaginable), reported by the patient as their current anxiety at the time of query. Exploratory sub-endpoint to investigate the relationship between patient anxiety and pain scales.
Needle sticks to achieve anesthesia (count)	Perioperative: Before surgical excision	Total punctures during local infiltration punctures prior to first incision. Does not include punctures required for nerve blocks.
Total anesthetic volume (mL)	Perioperative: From the administration of the nerve block to the end of excision	Sum of all injected volumes (blocks + infiltration + preventative + rescue). Exploratory sub-endpoints will investigate infiltration-only volume to estimate infiltration-sparing effect of nerve blocks.
Rescue anesthesia required (yes/no)	Perioperative: Stage 1 of MMS	Proportion of participants receiving ≥1 rescue infiltration after initial complete anesthesia is complete and before stage-1 end. Exploratory sub-endpoint to investigate the number of rescue events during stage 1.
Patient satisfaction (1-5)	Perioperative: End of stage 1 of MMS	Score from the five-point Likert scale assessing patient satisfaction, with higher scores indicating greater satisfaction.

Trial Locations

Locations (1)

Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States