Lidocaine Jelly for Pain Control During Mohs Surgery

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03595449
• Collaborator: (none)
• Enrollment: 233
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 233 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: Aug 13, 2018
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Mean Change in Patient Perception of Pain Score [baseline to stage 1 of Mohs surgery, approximately one hour]

   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."

Secondary Outcome Measures

1. Mean Total Amount of Intervention (Lidocaine or Surgilube) Used [Through completion of Mohs surgery, approximately one day]

   The mean total amount of intervention used as measured by milligrams (mg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Shari A Ochoa, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 21, 2018

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Shari Ochoa MD, Assistant Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03595449
• Other Study ID Numbers: 17-011142
• First Posted: Jul 23, 2018
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Lidocaine

Study Results

Participant Flow

Arm/Group Title	Lidocaine Jelly	Surgilube
Arm/Group Description	This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
Period Title: Overall Study
STARTED	118	115
COMPLETED	118	115
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lidocaine Jelly	Surgilube	Total
Arm/Group Description	This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery	Total of all reporting groups
Overall Participants	118	115	233
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.2 (10.46)	71.7 (11.38)	72.0 (10.90)
Sex: Female, Male (Count of Participants)
Female	44 37.3%	53 46.1%	97 41.6%
Male	74 62.7%	62 53.9%	136 58.4%
Race/Ethnicity, Customized (Count of Participants)
White	113 95.8%	109 94.8%	222 95.3%
Hispanic	2 1.7%	0 0%	2 0.9%
Asian/Pacific Islander	0 0%	1 0.9%	1 0.4%
Other	1 0.8%	0 0%	1 0.4%
Unknown	2 1.7%	5 4.3%	7 3%
Region of Enrollment (participants) [Number]
United States	118 100%	115 100%	233 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Patient Perception of Pain Score
Description	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."
Time Frame	baseline to stage 1 of Mohs surgery, approximately one hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Jelly	Surgilube
Arm/Group Description	This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
Measure Participants	118	115
Mean (95% Confidence Interval) [score on a scale]	0.5	0.3

2. Secondary Outcome

Title	Mean Total Amount of Intervention (Lidocaine or Surgilube) Used
Description	The mean total amount of intervention used as measured by milligrams (mg)
Time Frame	Through completion of Mohs surgery, approximately one day

Outcome Measure Data

Analysis Population Description

Data was not collected or analyzed for four subjects in each arm

Arm/Group Title	Lidocaine Jelly	Surgilube
Arm/Group Description	This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery	This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
Measure Participants	111	114
Mean (Standard Deviation) [mg]	28.1 (29.0)	24.4 (18.80)

Adverse Events

Time Frame	Adverse events were collected from baseline to end of study, approximately one day for each subject
Arm/Group Title	Lidocaine Jelly		Surgilube
Arm/Group Description	This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery		This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
All Cause Mortality
	Lidocaine Jelly		Surgilube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/115 (0%)
Serious Adverse Events
	Lidocaine Jelly		Surgilube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/115 (0%)
Other (Not Including Serious) Adverse Events
	Lidocaine Jelly		Surgilube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/115 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.