Anesthesia for Skin Cancer

CR
CR
KM
Overseen ByKaiyu Ma Clinical research regulatory specialist, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
Stay on Your Current MedsYou can continue your current medications while participating

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding regional nerve blocks (a type of anesthesia) can reduce pain and anxiety in individuals undergoing Mohs surgery for skin cancer on the face or scalp. Participants will be randomly assigned to receive either a placebo nerve block or a nerve block with lidocaine (a local anesthetic), in addition to the usual anesthesia for complete numbness. It is suitable for adults scheduled for Mohs surgery with skin cancer on the face or scalp, particularly if the cancer is large or located on sensitive areas like the lip, nose, or eyelid. As an unphased trial, it provides a unique opportunity to explore innovative pain management techniques during surgery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you use sedatives or anxiety medications before the procedure, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lidocaine is generally very safe for use in skin cancer surgeries. Studies confirm that the amounts used in procedures like Mohs surgery remain well within safe limits. Lidocaine toxicity is extremely rare, almost non-existent. When lidocaine numbs the skin during surgery, patients usually tolerate it well, with very few serious side effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new technique for managing pain in skin cancer surgeries. Unlike the standard approach, which often involves general anesthesia or simple local anesthesia, this trial looks at using a regional nerve block with lidocaine to target pain more precisely. This method could potentially reduce the need for larger doses of anesthetic and improve patient comfort and recovery times. By comparing this to a placebo nerve block, researchers hope to determine if this technique provides superior pain management and overall outcomes for patients undergoing skin cancer surgery.

What evidence suggests that this trial's treatments could be effective for reducing pain and anxiety in skin cancer surgery?

Research has shown that using lidocaine to numb specific areas can reduce pain and anxiety during surgeries. In this trial, participants will receive either a regional nerve block with lidocaine or a placebo nerve block. For cancer patients, lidocaine patches have effectively managed short-term pain. Studies indicate that applying lidocaine around a tumor before surgery can improve survival rates in breast cancer patients. Additionally, lidocaine has demonstrated potential benefits in treating some types of skin cancer. These findings suggest that lidocaine could reduce discomfort during Mohs surgery for skin cancer on the face and scalp.678910

Who Is on the Research Team?

CM

Christopher Miller, MD

Principal Investigator

Univerisity of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults with skin cancer on the face or scalp, specifically basal cell carcinoma or melanoma. Participants must be undergoing Mohs micrographic surgery (MMS). People who have conditions that might interfere with the study or pose a risk to their safety are not eligible.

Inclusion Criteria

I am 18 years old or older.
I am scheduled for a skin cancer removal surgery.
I have lesions on my face or scalp.
See 2 more

Exclusion Criteria

Inability to understand or complete pain and satisfaction assessments
Pregnant or breastfeeding
I have signs of infection in the skin or soft tissues where I received an injection or nerve block.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Mohs micrographic surgery with either placebo or adjunct regional nerve block

1 day
1 visit (in-person)

Perioperative Assessment

Pain and anxiety are assessed at multiple time points during the surgery using Visual Analog Scales

Same day as treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lidocaine
Trial Overview The study is testing if using regional nerve blocks can reduce pain and anxiety during MMS. Patients will either receive a fake nerve block with saline (saltwater) or a real one with lidocaine, in addition to local anesthesia already provided by lidocaine.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Regional Nerve BlockExperimental Treatment1 Intervention
Group II: Placebo Nerve BlockPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

Local Anesthetic Lidocaine and Cancer: Insight Into Tumor ...Lidocaine 5% patches is effective in the short-term for the treatment of neuropathic cancer pain accompanied by allodynia. Salas and Colleagues ...
Anesthesia (Numbing Medicine) in Mohs Surgery for Skin ...This study seeks to determine whether adjunct regional nerve blocks reduce pain and anxiety in adult patients undergoing Mohs micrographic ...
The role of lidocaine in cancer progression and patient ...Local administration of lidocaine around the tumor immediately prior to surgical removal has been shown to improve overall survival in breast cancer patients.
The Role of Lidocaine in Cancer Progression and Patient ...Local administration of lidocaine around the tumor immediately prior to surgical removal has been shown to improve overall survival in breast cancer patients.
(PDF) An Analysis of Lidocaine Usage in the Treatment ...This review analyzes the usage of lidocaine in the treatment of SCC. It was also discovered that lidocaine, as an agent, has the potential to ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/27893492/
Safety of Local Intracutaneous Lidocaine Anesthesia Used ...Volumes of lidocaine in skin cancer excision and repair are modest and within safe limits. Lidocaine toxicity is exceedingly rare to entirely absent.
An Analysis of Lidocaine Usage in the Treatment ...Mohs surgery is a safe and effective procedure for eliminating SCC. This surgery requires the usage of an analgesic known as lidocaine.
Effect of lidocaine on the safety of postoperative skin ...The aim of this study was to assess the effect of lidocaine on skin healing and immune function after operation of patients with melanoma.
NCT00594542 | Comparison of the Total Dose and Efficacy ...This randomized, double-blind study will systematically compare the total dose of 1.0% lidocaine with 1:100,000 epinephrine versus 0.5% of lidocaine with 1: ...
Local Anesthetic Lidocaine and Cancer: Insight Into Tumor ...Evidence from clinical and laboratory studies have suggested that lidocaine is beneficial to cancer patients by reducing cancer progression and recurrence and ...
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