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E-MOHS Trial of TENS and Vibration During Local Anesthesia

ConditionsPainProcedural PainLocal AnesthesiaMohs SurgerySkin Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

The E-MOHS Trial is a randomized controlled trial evaluating whether active vibration plus transcutaneous electrical nerve stimulation reduces pain during local anesthetic infiltration in adults undergoing Mohs micrographic surgery or dermatologic excision.

Participants will be randomized to active vibration:TENS or sham TENS during the first local anesthetic administration. The primary outcome is patient-reported infiltration pain during active local anesthetic infiltration, measured using the 11-point Numeric Rating Scale.

Secondary outcomes include infiltration pain measured using a Visual Analog Scale, perioperative anxiety, participant satisfaction, willingness to reuse the device, operator-rated ease of use and sterile-field compatibility, blinding integrity, and adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years of age or older scheduled for Mohs micrographic surgery under local anesthesia at a University of Minnesota or M Health Fairview dermatologic surgery clinic, or scheduled for dermatologic excision under local anesthesia as a pre-specified secondary population

Able to understand and rate pain on the 11-point Numeric Rating Scale and 100 mm Visual Analog Scale

Naive to transcutaneous electrical nerve stimulation, defined as no prior TENS exposure

English-speaking and able to provide informed consent in English

Disqualifiers

Implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic device

Surgical site requiring electrode placement over the anterior neck or carotid sinus region

Pregnancy

Epilepsy or other seizure disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Vibration:TENS

    Device

    Active high-frequency transcutaneous electrical nerve stimulation will be applied with adhesive electrodes placed outside the sterile field during local anesthetic infiltration. Stimulation will be titrated to a strong but comfortable, non-painful paresthesia and used with vibratory distraction adjacent to the injection site.

  • Sham TENS

    Device

    Sham transcutaneous electrical nerve stimulation will use a transient fade-to-zero current so that device titration appears similar to active treatment while preserving participant blinding.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Active Vibration:TENSExperimental treatment 1 intervention
Group B: Sham TENSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain During Local Anesthetic Infiltration Measured by Numeric Rating Scale

Patient-reported pain during local anesthetic infiltration will be measured using the 11-point Numeric Rating Scale, ranging from 0 to 10, during active infiltration at the first anesthetic administration.

Time frame
During active local anesthetic infiltration at the first anesthetic administration

Secondary outcomes

1

Pain During Local Anesthetic Infiltration Measured by Visual Analog Scale

Patient-reported pain during local anesthetic infiltration will be measured using the 100 mm Visual Analog Scale.

Time frame
During active local anesthetic infiltration at the first anesthetic administration
2

Perioperative Anxiety Measured by Visual Analog Scale

Perioperative anxiety will be assessed using a 100 mm Visual Analog Scale. Participants will mark their anxiety level on a scale from 0 mm to 100 mm, with higher scores indicating greater anxiety.

Time frame
Before local anesthetic administration on the day of surgery
3

Participant Satisfaction With the Infiltration Experience

Participant satisfaction with the local anesthetic infiltration experience will be assessed after the procedure using study-specific participant-reported measures.

Time frame
Before local anesthetic administration on the day of surgery
4

Willingness to Reuse the Device

Participant willingness to use the device again in a future procedure will be assessed after the procedure.

Time frame
After the procedure on the day of surgery

Other outcomes

Sponsors and contacts

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

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: