Lidocaine Jelly for Pain Control During Mohs Surgery

NCT ID: NCT03595449

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2020-08-31

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?

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.

Conditions

Pain; Satisfaction, Consumer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Lidocaine jelly

This is the group that will have lidocaine jelly applied during Mohs surgery

Group Type: ACTIVE_COMPARATOR

Lidocaine jelly

Intervention Type: DRUG

lidocaine 2% jelly applied during Mohs surgery

Surgilube

This is the group that will have surgilube (placebo) applied during Mohs surgery

Group Type: SHAM_COMPARATOR

Surgilube

Intervention Type: DRUG

surgilube (placebo) applied during Mohs surgery

Interventions

Lidocaine jelly

lidocaine 2% jelly applied during Mohs surgery

Intervention Type: DRUG

Surgilube

surgilube (placebo) applied during Mohs surgery

Intervention Type: DRUG

Other Intervention Names

lidocaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Shari Ochoa MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shari A Ochoa, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

17-011142

Identifier Type: -

Identifier Source: org_study_id