NCT03871478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

March 1, 2019

Last Update Submit

June 12, 2020

Conditions

LidocaineBupivacaineMohs SurgeryAnesthetic

Outcome Measures

Primary Outcomes (1)

  • Wong-Baker FACES Pain Rating Scale

    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).

    2, 4, 6, 8, 12, 24, 36, and 72 hours

Secondary Outcomes (3)

  • Adverse Event

    1 week post-op

  • Post-Operative Infection

    1 week post-op

  • Post-Operative Bleeding

    1 week post-op

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Lidocaine and Bupivacaine

ACTIVE COMPARATOR

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

Interventions

LidocaineDRUG

See Arm Description

Lidocaine
BupivacaineDRUG

See Arm Description

Bupivacaine
Lidocaine and BupivacaineDRUG

See Arm Description

Lidocaine and Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Confirmed diagnosis of non-melanoma skin cancer
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohs Surgery Clinic

Ottawa, Ontario, K1H 7W9, Canada

RECRUITING

Related Publications (10)

  • Bouloux GF, Punnia-Moorthy A. Bupivacaine versus lidocaine for third molar surgery: a double-blind, randomized, crossover study. J Oral Maxillofac Surg. 1999 May;57(5):510-4; discussion 515. doi: 10.1016/s0278-2391(99)90063-0.

    PMID: 10319823RESULT

  • Firoz BF, Goldberg LH, Arnon O, Mamelak AJ. An analysis of pain and analgesia after Mohs micrographic surgery. J Am Acad Dermatol. 2010 Jul;63(1):79-86. doi: 10.1016/j.jaad.2009.10.049.

    PMID: 20542176RESULT

  • Tetzlaff JE. The pharmacology of local anesthetics. Anesthesiol Clin North Am. 2000 Jun;18(2):217-33, v. doi: 10.1016/s0889-8537(05)70161-9.

    PMID: 10935008RESULT

  • Koay J, Orengo I. Application of local anesthetics in dermatologic surgery. Dermatol Surg. 2002 Feb;28(2):143-8. doi: 10.1046/j.1524-4725.2002.01126.x.

    PMID: 11860425RESULT

  • Christensen J, Matzen LH, Vaeth M, Wenzel A, Schou S. Efficiency of bupivacaine versus lidocaine and methylprednisolone versus placebo to reduce postoperative pain and swelling after surgical removal of mandibular third molars: a randomized, double-blinded, crossover clinical trial. J Oral Maxillofac Surg. 2013 Sep;71(9):1490-9. doi: 10.1016/j.joms.2013.05.001. Epub 2013 Jul 15.

    PMID: 23866780RESULT

  • Kaurich MJ, Otomo-Corgel J, Nagy RJ. Comparison of postoperative bupivacaine with lidocaine on pain and analgesic use following periodontal surgery. J West Soc Periodontol Periodontal Abstr. 1997;45(1):5-8.

    PMID: 9477866RESULT

  • Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10.

    PMID: 17052624RESULT

  • Su N, Liu Y, Yang X, Shi Z, Huang Y. Efficacy and safety of mepivacaine compared with lidocaine in local anaesthesia in dentistry: a meta-analysis of randomised controlled trials. Int Dent J. 2014 Apr;64(2):96-107. doi: 10.1111/idj.12087. Epub 2014 Jan 16.

    PMID: 24428507RESULT

  • Thomson CJ, Lalonde DH. Randomized double-blind comparison of duration of anesthesia among three commonly used agents in digital nerve block. Plast Reconstr Surg. 2006 Aug;118(2):429-32. doi: 10.1097/01.prs.0000227632.43606.12.

    PMID: 16874214RESULT

  • Yilmaz YF, Ozlugedik S, Titiz A, Tuncay A, Ozcan M, Unal A. Comparison of levo-bupivacaine and lidocaine for postoperative analgesia following septoplasty. Rhinology. 2008 Dec;46(4):289-91.

    PMID: 19145998RESULT

MeSH Terms

Interventions

LidocaineBupivacaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jillian A Macdonald, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian A Macdonald, MD

CONTACT

6137388400jimacdonald@toh.ca

Megan C Lim, MD

CONTACT

6138891927melim@toh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 12, 2019

Study Start

October 1, 2019

Primary Completion

March 31, 2021

Study Completion

June 14, 2021

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)