Mohs Micrographic Surgery, Anesthesia, Local
Conditions
Brief summary
To compare several local anesthetics when used during dermatological surgery.
Detailed description
This study is a randomized, controlled trial comparing the effectiveness of several local anesthetics, including lidocaine, mepivacaine, bupivacaine, and chlorprocaine when used for Mohs Microscopic Surgery (MMS) to see which is the most effective.
Interventions
DRUGLidocaine
Standard of Care drug
DRUGBupivacaine Hydrochloride
Study Drug
Study Drug
DRUGChlorprocaine
Study Drug
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* adults 18-89 years old * individuals with a cutaneous tumor treated by MMS
Exclusion criteria
* individuals younger than 18 and older than 89 * pregnant individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine if pain increases with local injections at each stage of surgery. | 5 mins, 15 mins, 20 mins, 25 mins, 30 mins, 45 mins (reconstruction) | Assess changes in pain levels by determining if longer acting agents such as bupivacaine or bupivacaine with epinephrine will show lower reported pain scores by patients compared to shorter acting anesthetic agents such as lidocaine with epinephrine or mepivacaine when undergoing Mohs micrographic surgery. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain control using mepivacaine as a primary anesthetic agent | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Determine if using mepivacaine as the primary anesthetic will lower the patient verbally reported pain scores. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible. |
| Pain control using bupivacaine with epinephrine as a primary anesthetic agent | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Determine change in patients verbally reported pain scale when using bupivacaine with epinephrine as the primary anesthetic. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible. |
| Pain control using bupivacaine as a primary anesthetic agent | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Determine change in patients verbally reported pain scale when using bupivacaine as the primary anesthetic. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible. |
| Ideal anesthetic agents for varying sizes of tumors | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Determine which anesthetic works best for different size tumors. This will be measured using pain scores throughout the procedure prior to taking the stage as the patient will be numb after the stage is taken. The visual analog scale (VAS) of 1-10 will be used, where 1 means no pain and 10 is worst pain possible. |
| Ideal anesthetic agents for varying anatomic location of tumors | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Determine which anesthetic works best for tumors in different locations of the body. This will be measured using pain scores throughout the procedure prior to taking the stage as the patient will be numb after the stage is taken. The visual analog scale (VAS) of 1-10 will be used, where 1 means no pain and 10 is worst pain possible. |
| Overall tolerability of MMS | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Assess patients ability to tolerate the surgery with different anesthetics. This will be measured using pain scores throughout the procedure prior to taking the stage as the patient will be numb after the stage is taken. The visual analog scale (VAS) of 1-10 will be used, where 1 means no pain and 10 is worst pain possible. |
| General length of time required for various steps of MMS | 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction) | Assess the length of time it took to move from one stage to the next. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStan Tolkachjov, MD
Baylor Scott and White Health
Outcome results
None listed