Comparing the Efficacy of Local Anesthetics in Mohs Surgery
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Wong-Baker FACES Pain Rating Scale
Study Overview
Brief Summary
Mohs surgery is a very effective option in removing non-melanoma skin cancers, as the tissue being removed is analyzed the same day. If there are remnants of cancer cells in the tissue removed, the Mohs surgeon will go back and remove further tissue and repair the surgical wound all within the same day.
Unfortunately, postoperative pain is quite prevalent among patients requiring Mohs procedures, as up to 52% require an additional oral pain medication. Lidocaine is the most commonly used anesthetic used in Mohs given its rapid onset of action. However, the duration of lidocaine's effect is much shorter than bupivacaine, which may translate into increased postoperative pain.
To date, there are no specific studies comparing bupivacaine alone, lidocaine alone or both in conjunction in Mohs procedures.
The investigators predict bupivacaine alone and bupivacaine used in conjunction with lidocaine are more effective in managing pain during Mohs surgery than lidocaine alone.
To test our hypothesis, the investigators plan to have 105 patients receive either lidocaine alone, bupivacaine alone, or lidocaine and bupivacaine in conjunction during their Mohs procedure. Pain will be evaluated at various time points throughout the surgery.
Detailed Description
Mohs surgery is a very effective option in removing non-melanoma skin cancers, as the tissue being removed is analyzed the same day. If there are remnants of cancer cells in the tissue removed, the Mohs surgeon will go back and remove further tissue and repair the surgical One option for treating non-melanoma skin cancer is Mohs Surgery, also known as Mohs Micrographic Surgery or Mohs Procedure.
Mohs surgery is a full-day procedure where your skin cancer will be removed and processed immediately after in our lab. The investigators look at the edges of the skin that the investigators have removed to see if there is any cancer left. If any of the edges show that there is still cancer, the investigators go back and remove more. The investigators will repeat this process until all of the margins of your skin are clear from cancer. After all the cancer is removed, the investigators will reconstruct the area that has been removed to give you the best cosmetic and functional result.
Throughout this procedure, the investigators will inject local anesthetic or "freezing" to reduce the discomfort associated with skin cancer surgery. There are two different types of local anesthetic that the investigators are studying to reduce this pain. One anesthetic is called lidocaine and the other is bupivacaine. A third option is to use a combination of lidocaine and bupivacaine. Lidocaine and bupivacaine are both approved by Health Canada for its use in providing local anesthesia.
WHY IS THIS STUDY BEING DONE? The purpose of this study is to look at which of the approved interventions (lidocaine, bupivacaine or a combination of the two injected sequentially) works best to reduce pain during and after Mohs surgery.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? It is anticipated that about 105 people will take part in this study from The Mohs Clinic at the Parkdale Dermatology Clinic of The Ottawa Hospital.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Confirmed diagnosis of non-melanoma skin cancer
- •Written informed consent
Exclusion Criteria
- •Documented or reported history of adverse reaction to lidocaine or bupivacaine
- •Active soft tissue infection at site of surgery
- •Participants who require more than 3 stages of excision
Arms & Interventions
Lidocaine
Buffered lidocaine 1% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage
Intervention: Lidocaine (Drug)
Bupivacaine
Bupivacaine 0.5% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage
Intervention: Bupivacaine (Drug)
Lidocaine and Bupivacaine
Buffered lidocaine 1% with epinephrine 1:200,000 and bupivacaine 0.5% with epinephrine 1:200,000 injected sequentially.
Injected at the start of every Mohs excision stage
Intervention: Lidocaine and Bupivacaine (Drug)
Outcomes
Primary Outcomes
Wong-Baker FACES Pain Rating Scale
Time Frame: 2, 4, 6, 8, 12, 24, 36, and 72 hours
The Wong-Baker Pain Scale is a validated tool used around the world for to quantify patients amount of pain. The score ranges from 0 (no pain) to 10 (worst pain).
Secondary Outcomes
- Adverse Event(1 week post-op)
- Post-Operative Infection(1 week post-op)
- Post-Operative Bleeding(1 week post-op)