[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07222241":3,"trial-entities:NCT07222241":69,"trial-summary:NCT07222241":69},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":88,"locations":91,"central_contacts":101,"overall_officials":102,"references":107,"see_also_links":108},"NCT07222241","UPCC 10625","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","COMPLETED","2026-06-26","2026-09","2026-09-04","2026-01-27","Abramson Cancer Center at Penn Medicine","OTHER",true,"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:\n\n1. 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.\n2. 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.\n\nPain 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.",[19,20],"Skin Cancer Face","Skin Cancer Scalp",[22,23],"Mohs","Nerve block","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},132,"ACTUAL",[32,37],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Nerve Block","0.45% lidocaine with 1:200,000 epinephrine",[36],"Regional Nerve Block",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Placebo Nerve Block","Sterile normal saline",[38],[42],{"measure":43,"description":44,"timeFrame":45},"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.",[47,51,55,59,63],{"measure":48,"description":49,"timeFrame":50},"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.","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.",{"measure":52,"description":53,"timeFrame":54},"Needle Sticks","Number of needle sticks needed during local infiltration to achieve complete anesthesia. Does not include punctures used to assess numbness.","During local infiltration.",{"measure":56,"description":57,"timeFrame":58},"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.","From the administration of the first nerve block to the end of stage 1.",{"measure":60,"description":61,"timeFrame":62},"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.","Stage 1 of Mohs micrographic surgery.",{"measure":64,"description":65,"timeFrame":66},"Patient Satisfaction","Score from a five-point Likert scale assessing patient satisfaction. Higher scores indicate greater satisfaction.","Assessed at the end of stage 1 of Mohs micrographic surgery.","ALL","18 Years",null,false,{"inclusion":72,"exclusion":78,"raw_text":87},[73,74,75,76,77],"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.",[79,80,81,82,83,84,85,86],"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.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Scheduled to undergo MMS.\n* 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.\n* Tumor diameter plus anticipated stage 1 MMS margin ≥2 cm in diameter OR any tumor on the ear, lip, nose, or eyelid.\n* Ability to complete patient reported outcome measures in English.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to lidocaine or epinephrine.\n* Chronic opioid use or pre existing pain disorders that may interfere with pain reporting.\n* Presence of scar tissue at the anatomic site of local infiltration or nerve block that may alter anesthetic penetration.\n* Concurrent multi site Mohs procedure.\n* Signs of skin and soft tissue infection at the anatomic site of local infiltration or nerve block.\n* Inability to understand or complete pain and satisfaction assessments.\n* Pregnant or breastfeeding.\n* Use of sedatives or anxiolytics prior to the procedure.",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"Perelman Center for Advanced Medicine","Philadelphia","Pennsylvania","19104","United States",{"lat":99,"lon":100},39.95238,-75.16362,[],[103],{"name":104,"affiliation":105,"role":106},"Christopher Miller, MD","Univerisity of Pennsylvania","PRINCIPAL_INVESTIGATOR",[],[]]