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Lidocaine Jelly for Pain Control During Mohs Surgery

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ClinicalTrials.gov Identifier: NCT03595449
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Shari Ochoa MD, Mayo Clinic

Brief Summary:

Does the use of lidocaine jelly during Mohs surgery on the nose decrease the total amount of lidocaine used during surgery.

Does patient satisfaction improve when lidocaine jelly is used during Mohs surgery of the nose?


Condition or disease Intervention/treatment Phase
Pain Satisfaction, Consumer Drug: Lidocaine jelly Drug: Surgilube Phase 4

Detailed Description:

Hypothesis: Supplementing lidocaine/epinephrine injections with intralesional lidocaine jelly will decrease the overall quantity of lidocaine/epinephrine injectable used, and will decrease patients' self-reported pain/anxiety associated with needle sticks.

Objectives: To assess how using lidocaine jelly in Mohs surgery impacts 1) the overall quantity of lidocaine/epinephrine injectable needed to maintain anesthesia, and 2) patients' pain/anxiety associated with anesthesia injections.

Background:

Mohs micrographic surgery is a procedure that removes cancerous lesions of the skin in a step-wise fashion. Patients are injected with local analgesia for tumor extirpation. The tumor is removed and the tissue is sent for histopathology while the patient waits. Tissue processing time can take up to 2 hours during which the effects of the local analgesia have waned. Once the tissue has been process and examined, patients are brought back to the surgical suite and either have another section of tissue removed (if the margins were positive) or have the wound reconstructed (if the margins were negative). Lidocaine Hydrochloride (Xylocaine) injection with Epinephrine is the traditionally method used to maintain local anesthesia throughout the procedure. The FDA has declared a shortage of this injectable Lidocaine/Epinephrine, stressing the need for a substitute drug. Additionally, multiple needle sticks can be uncomfortable and anxiety provoking for patients. Needle sticks on hypersensitive areas such as the nose can be particularly painful. Previous research has demonstrated that a different form of anesthetic, a topical lidocaine jelly, is efficient in prolonging anesthesia in Mohs surgery (Robins, 1991). No study has published the impact of supplemental lidocaine jelly use on the overall quantity of injection needed, nor on patient pain/anxiety associated with needle sticks.

Methods:

We will conduct a prospective, randomized trial of 250 patients receiving Mohs micrographic surgery to lesions on the nose. Annually Mohs micrographic surgery is performed on approximately 900 patients with 30% of these procedures being performed on lesions on the nose. Patients receiving Mohs treatment for lesions on the nose will be randomly assigned to one of two groups: (1) those whose wounds will be dressed with lidocaine jelly (treatment group), and (2) those whose wounds will be dressed with surgical lubricant (control/placebo group).

All patients will receive a pre-treatment baseline pain/anxiety survey followed by an initial lidocaine injection. The amount of lidocaine/epinephrine injection each patient receives throughout remaining stages of surgery will be recorded, as per the current workflow. All patients will complete a second pain/anxiety survey immediately after numbing but prior to the first stage of surgery.

After the first stage of surgery, either lidocaine jelly or surgical lubricant will be applied to the wound followed by a pressure bandage as per standard practice. Dressing are removed immediately prior to the next stage of surgery. After each subsequent stage of surgery, an identical wound dressing will be placed on the operative site.

Immediately prior to each subsequent stage of surgery, we will assess patients' pain sensation, and additional lidocaine/epinephrine will be injected if needed. After the surgical site is re-anesthetized, vital signs will be recorded and the Pain/Anxiety survey administered immediately prior to the first incision of that stage.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Patient Satisfaction in Mohs Micrographic Surgery With Supplemental Lidocaine Jelly
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine jelly
This is the group that will have lidocaine jelly applied during Mohs surgery
Drug: Lidocaine jelly
lidocaine 2% jelly applied during Mohs surgery
Other Name: lidocaine

Sham Comparator: Surgilube
This is the group that will have surgilube (placebo) applied during Mohs surgery
Drug: Surgilube
surgilube (placebo) applied during Mohs surgery




Primary Outcome Measures :
  1. patient perception of pain during Mohs surgery using patient questionnaire [ Time Frame: immediately after each surgical stage ]
    Descriptive statistics for measures of pain


Secondary Outcome Measures :
  1. Volume of injected lidocaine required for Mohs surgery [ Time Frame: This study is during a single surgical encounter. Total volume of injected lidocaine used will be recorded at the end of the surgical procedure. These surgeries can last less than 1 hour up to 8 hours total volume depends on surgery time ]
    how much injected lidocaine is needed to maintain anesthesia in the treatment group versus placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Patients having Mohs surgery on the nose who are able to consent to the study >18 years old

Exclusion criteria:

unable to consent for themselves known allergy to lidocaine Mohs surgery in locations other than the nose


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595449


Contacts
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Contact: Shari Ochoa, MD 480-301-6899 ochoa.shari@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Shari Ochoa, MD    480-301-6899    ochoa.shari@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shari A Ochoa, MD Mayo Clinic
Additional Information:
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Responsible Party: Shari Ochoa MD, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03595449    
Other Study ID Numbers: 17-011142
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action