Comparing Numbing Techniques in Mohs Micrographic Surgery

Abramson Cancer Center at Penn Medicine150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

Conditions

Skin Cancer Face Skin Cancer Scalp

Interventions

Nerve BlockOTHER

0.45% lidocaine with 1:200,000 epinephrine

Placebo Nerve BlockOTHER

Sterile normal saline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Intraoperative Pain

Pain rating reported by the patient using a Visual Analog Scale (0 = no pain; 10 = worst pain imaginable).

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.

Secondary Outcomes

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.

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

Number of needle sticks needed during local infiltration to achieve complete anesthesia. Does not include punctures used to assess numbness.

Time frame: 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.

Time frame: 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.

Time frame: Stage 1 of Mohs micrographic surgery.

Patient Satisfaction

Score from a five-point Likert scale assessing patient satisfaction. Higher scores indicate greater satisfaction.

Central Contacts

Kaiyu Ma Clinical research regulatory specialist, PhD

CONTACT

215-662-2123 makaiyu@pennmedicine.upenn.edu

Christopher Richter, BS

CONTACT

christopher.richter1@pennmedicine.upenn.edu

Data from ClinicalTrials.gov

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