Recruiting

Local Anesthetics

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03871478

Conditions

Lidocaine

Bupivacaine

Mohs Surgery

Anesthetic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Bupivacaine

Lidocaine and Bupivacaine

Study Details

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.

Conditions

Lidocaine

Bupivacaine

Mohs Surgery

Anesthetic

Study ID

NCT03871478

Start date

Oct 1, 2019

Status verified date

Jun, 2020

Completion date

Jun 14, 2021

Anticipated

Primary completion date

Mar 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lidocaine

Buffered lidocaine 1% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage

active comparator: Bupivacaine

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

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

Interventions

Lidocaine

See Arm Description

Bupivacaine

See Arm Description

Lidocaine and Bupivacaine

See Arm Description

Primary outcome measure

  • Wong-Baker FACES Pain Rating Scale [ Time Frame: 2, 4, 6, 8, 12, 24, 36, and 72 hours ]

Central Contacts and Locations

Central contacts

Jillian A Macdonald, MD

6137388400jimacdonald@toh.ca

Locations

Mohs Surgery Clinic

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Contacts

Jillian A Macdonald, MD

6137388400jimacdonald@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jun 16, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-06-16.