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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Nerve Block | Placebo Comparator | Placebo regional nerve block with sterile normal saline plus local anesthetic infiltration of the tumor site. |
|
| Regional Nerve Block | Experimental | Adjunct regional nerve block with lidocaine plus local anesthetic infiltration of the tumor site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Block | Other | 0.45% lidocaine with 1:200,000 epinephrine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaiyu Ma Clinical research regulatory specialist, PhD | Contact | 215-662-2123 | makaiyu@pennmedicine.upenn.edu | |
| Christopher Richter, BS | Contact | christopher.richter1@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Miller, MD | Univerisity of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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.
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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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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| Placebo Nerve Block |
| Other |
Sterile normal saline |
|
| 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. |
| 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. |
| 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. |
| 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. |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |