Lidocaine Jelly for Pain Control During Mohs Surgery

NCT03595449 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-011142
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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?

Conditions

Pain; Satisfaction, Consumer

Outcome Measures

Primary Outcomes (1)

• Mean Change in Patient Perception of Pain Score

  The mean change of total pain score of patient perception of pain. As measured by the question "Rate the pain of your nose from 0 to 10. 0 being no pain, 10 being the worst pain of your life."

  baseline to stage 1 of Mohs surgery, approximately one hour

Secondary Outcomes (1)

• Mean Total Amount of Intervention (Lidocaine or Surgilube) Used

  Through completion of Mohs surgery, approximately one day

Study Arms (2)

Lidocaine jelly

ACTIVE COMPARATOR

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

Drug: Lidocaine jelly

Surgilube

SHAM COMPARATOR

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

Drug: Surgilube

Interventions

Lidocaine jelly DRUG

lidocaine 2% jelly applied during Mohs surgery

Also known as: lidocaine

Lidocaine jelly

Surgilube DRUG

surgilube (placebo) applied during Mohs surgery

Surgilube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain; Consumer Behavior

Interventions

Lidocaine; phenylmercury borate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Shari A. Ochoa, M.D.
• Organization: Mayo Clinic

Ochoa.Shari@mayo.edu

480-301-6479

Study Officials

• Shari A Ochoa, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: July 23, 2018
• Study Start: August 13, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: July 13, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)