Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT07222241
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.45% lidocaine with 1:200,000 epinephrine
Sterile normal saline
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).
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.
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: During local infiltration.
Number of needle sticks needed during local infiltration to achieve complete anesthesia. Does not include punctures used to assess numbness.
Time frame: From the administration of the first nerve block to the end of stage 1.
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: Stage 1 of Mohs micrographic surgery.
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: Assessed at the end of stage 1 of Mohs micrographic surgery.
Score from a five-point Likert scale assessing patient satisfaction. Higher scores indicate greater satisfaction.
Abramson Cancer Center at Penn Medicine
Other
Randomized, Double-Blind, Placebo-Controlled Trial of Adjunct Nerve Blocks in Mohs Micrographic Surgery on the Face and Scalp
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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