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Lidocaine Jelly for Pain Control During Mohs Surgery

Patient Satisfaction in Mohs Micrographic Surgery With Supplemental Lidocaine Jelly

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03595449
Enrollment
233
Registered
2018-07-23
Start date
2018-08-13
Completion date
2020-08-31
Last updated
2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Satisfaction, Consumer

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.

Interventions

lidocaine 2% jelly applied during Mohs surgery

surgilube (placebo) applied during Mohs surgery

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Patient Perception of Pain Scorebaseline to stage 1 of Mohs surgery, approximately one hourThe 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

MeasureTime frameDescription
Mean Total Amount of Intervention (Lidocaine or Surgilube) UsedThrough completion of Mohs surgery, approximately one dayThe mean total amount of intervention used as measured by milligrams (mg)

Countries

United States

Participant flow

Participants by arm

ArmCount
Lidocaine Jelly
This group had lidocaine jelly applied during Mohs surgery Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery
118
Surgilube
This group had surgilube (placebo) applied during Mohs surgery Surgilube: surgilube (placebo) applied during Mohs surgery
115
Total233

Baseline characteristics

CharacteristicLidocaine JellySurgilubeTotal
Age, Continuous72.2 years
STANDARD_DEVIATION 10.46
71.7 years
STANDARD_DEVIATION 11.38
72.0 years
STANDARD_DEVIATION 10.9
Race/Ethnicity, Customized
Asian/Pacific Islander
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Other
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Unknown
2 Participants5 Participants7 Participants
Race/Ethnicity, Customized
White
113 Participants109 Participants222 Participants
Region of Enrollment
United States
118 participants115 participants233 participants
Sex: Female, Male
Female
44 Participants53 Participants97 Participants
Sex: Female, Male
Male
74 Participants62 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1180 / 115
other
Total, other adverse events
0 / 1180 / 115
serious
Total, serious adverse events
0 / 1180 / 115

Outcome results

Primary

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.

Time frame: baseline to stage 1 of Mohs surgery, approximately one hour

ArmMeasureValue (MEAN)
Lidocaine JellyMean Change in Patient Perception of Pain Score0.5 score on a scale
SurgilubeMean Change in Patient Perception of Pain Score0.3 score on a scale
Secondary

Mean Total Amount of Intervention (Lidocaine or Surgilube) Used

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

Time frame: Through completion of Mohs surgery, approximately one day

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

ArmMeasureValue (MEAN)Dispersion
Lidocaine JellyMean Total Amount of Intervention (Lidocaine or Surgilube) Used28.1 mgStandard Deviation 29
SurgilubeMean Total Amount of Intervention (Lidocaine or Surgilube) Used24.4 mgStandard Deviation 18.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026