Comparing the Efficacy of Local Anesthetics in Mohs Surgery
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|ClinicalTrials.gov Identifier: NCT03871478|
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : April 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Lidocaine Bupivacaine Mohs Surgery Anesthetic||Drug: Lidocaine Drug: Bupivacaine Drug: Lidocaine and Bupivacaine||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparing the Efficacy of Local Anesthetics in Mohs Surgery|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||August 14, 2021|
Active Comparator: Lidocaine
Buffered lidocaine 1% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage
See Arm Description
Active Comparator: Bupivacaine
Bupivacaine 0.5% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage
See Arm Description
Active Comparator: 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
Drug: Lidocaine and Bupivacaine
See Arm Description
- 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).
- Adverse Event [ Time Frame: 1 week post-op ]Adverse event to local anesthetic
- Post-Operative Infection [ Time Frame: 1 week post-op ]Post-operative infection requiring topical or systemic antibiotics
- Post-Operative Bleeding [ Time Frame: 1 week post-op ]Post-operative bleeding requiring surgical exploration/revision or hematoma evacuation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871478
|Contact: Jillian A Macdonald, MD||6137388400 ext email@example.com|
|Contact: Megan C Lim, MDfirstname.lastname@example.org|
|Mohs Surgery Clinic||Not yet recruiting|
|Ottawa, Ontario, Canada, K1H 7W9|
|Contact: Jillian A Macdonald, MD 6137388400 ext 81645 email@example.com|
|Contact: Derek C To, MD 6132185679 firstname.lastname@example.org|
|Principal Investigator:||Jillian A Macdonald, MD||The Ottawa Hospital|