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Comparing Numbing Techniques in Mohs Micrographic Surgery

ConditionsSkin Cancer FaceSkin Cancer Scalp
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nerve Block

    Other intervention

    0.45% lidocaine with 1:200,000 epinephrine

  • Placebo Nerve Block

    Other intervention

    Sterile normal saline

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Placebo Nerve BlockPlacebo comparator 1 intervention
Group B: Regional Nerve BlockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Source ClinicalTrials.gov
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