Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing the Efficacy of Local Anesthetics in Mohs Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03871478
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Richard J. MacKay Endowment Fund
Benefactor Life Members’ Research Grant
The Ottawa Hospital Division of Dermatology
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Lidocaine Bupivacaine Mohs Surgery Anesthetic Drug: Lidocaine Drug: Bupivacaine Drug: Lidocaine and Bupivacaine Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
Buffered lidocaine 1% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage
Drug: Lidocaine
See Arm Description

Active Comparator: Bupivacaine
Bupivacaine 0.5% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage
Drug: Bupivacaine
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Adverse Event [ Time Frame: 1 week post-op ]
    Adverse event to local anesthetic

  2. Post-Operative Infection [ Time Frame: 1 week post-op ]
    Post-operative infection requiring topical or systemic antibiotics

  3. Post-Operative Bleeding [ Time Frame: 1 week post-op ]
    Post-operative bleeding requiring surgical exploration/revision or hematoma evacuation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Confirmed diagnosis of non-melanoma skin cancer
  3. Written informed consent

Exclusion Criteria:

  1. Documented or reported history of adverse reaction to lidocaine or bupivacaine
  2. Active soft tissue infection at site of surgery
  3. Participants who require more than 3 stages of excision

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jillian A Macdonald, MD 6137388400 ext 81645 jimacdonald@toh.ca
Contact: Megan C Lim, MD 6138891927 melim@toh.ca

Locations
Layout table for location information
Canada, Ontario
Mohs Surgery Clinic Not yet recruiting
Ottawa, Ontario, Canada, K1H 7W9
Contact: Jillian A Macdonald, MD    6137388400 ext 81645    jimacdonald@toh.ca   
Contact: Derek C To, MD    6132185679    dto@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Richard J. MacKay Endowment Fund
Benefactor Life Members’ Research Grant
The Ottawa Hospital Division of Dermatology
Investigators
Layout table for investigator information
Principal Investigator: Jillian A Macdonald, MD The Ottawa Hospital

Publications of Results:

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03871478     History of Changes
Other Study ID Numbers: #20160131
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action