LidocaineNCT03871478
Comparing the Efficacy of Local Anesthetics in Mohs Surgery
A study testing Lidocaine, Bupivacaine and Lidocaine and Bupivacaine in people with Lidocaine and Bupivacaine, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lidocaine, Bupivacaine, Mohs Surgery
- What is being tested?
- Lidocaine, Bupivacaine and Lidocaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Confirmed diagnosis of non-melanoma skin cancer
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mohs Surgery Clinic
Ottawa, Ontario, K1H 7W9
Jillian A Macdonald, MD, 6137388400 ext. 81645, jimacdonald@toh.ca
Megan C LIM, MD, 6138891927, melim@toh.ca
About this study
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.
Read more
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.
Read the 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.
This study should take three months to complete and the results should be known in about 6 months.
ASSIGNMENT TO A GROUP If you decide to participate then you will be "randomized" into one of the groups described below. Randomization means that you are put into a group by chance (like flipping a coin). There is no way to predict which group you will be assigned to. You will have a one in three chance of being placed in either group. Neither you, the study staff, nor the study doctors can choose what group you will be in.
You will not know which group you are in, but the study doctor and study staff will.
WHAT IS THE STUDY INTERVENTION? Group 1: Lidocaine alone If you are randomized to this group you will receive lidocaine as your local anesthetic.
Group 2: Bupivacaine alone If you are randomized to this group you will receive bupivacaine as your local anesthetic.
Group 3: Lidocaine and bupivacaine used in combination If you are randomized to this group you will receive both lidocaine and bupivacaine used in combination during your procedure. First you will receive injections of lidocaine and then immediately afterwards you will receive injections of bupivacaine. Roughly equal volumes of lidocaine and bupivacaine will be used and the investigators expect the overall volume of local anesthetic (compared with group 1 and 2) that will be injected will be similar. The investigators expect the total number of needle pokes to be similar.
WHAT ELSE DO I NEED TO KNOW ABOUT THE STUDY INTERVENTION? All of the study interventions are considered standard of care for the use of local anesthetics in Mohs procedure. Local practices for using anesthetics are center dependent.
If you have side effects while you are on this study, the study doctor may make changes to the intervention.
If you require greater than three levels during your Mohs procedure, your data will be collected but will be excluded from the main study analysis. Patients requiring greater than three levels during their Mohs procedure are excluded because they often require more complex skin reconstruction surgery which can be more painful afterwards. The vast majority of patients undergoing Mohs surgery require one to three levels and it is these patients that the investigators are hoping to apply the results of our study to.
QUESTIONNAIRES As part of the study, you will be required to complete the same short questionnaire a total of nine times. This questionnaire will only be done by participants in this study.
The questionnaire will be completed at The Mohs Clinic just prior to your surgery and you will complete the questionnaire at home after your surgery at various time points (at 2, 4, 6, 8, 12, 24, 36 and 72 hours post surgery). The purpose of the questionnaire is assess the level of your surgical/incisional pain after Mohs surgery and enquire about any additional pain medications that you have taken after the surgery. It will take approximately 2 minutes to complete the questionnaire You will be asked to bring all of the completed questionnaires with you when you return to the Mohs Clinic for your follow-up visit one the investigatorsek after your surgery.
The information you provide is for research purposes only. You can choose not to ansthe investigatorsr questions if you wish.
Even though you may have provided information on a questionnaire, these responses will not be reviethe investigatorsd promptly by your health care team. If you wish them to know this information please bring it to their attention.
- Conditions
- Lidocaine, Bupivacaine, Mohs Surgery, Anesthetic
- Being tested
- Lidocaine, Bupivacaine, Lidocaine and Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
See Arm Description
BupivacaineDrug
See Arm Description
Lidocaine and BupivacaineDrug
See Arm Description
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Buffered lidocaine 1% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage Receives: Drug: Lidocaine |
| Bupivacaine | Active comparator | Bupivacaine 0.5% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage Receives: 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 Receives: Drug: Lidocaine and Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2, 4, 6, 8, 12, 24, 36, and 72 hours
Secondary outcomes (3)
Adverse Event
Adverse event to local anesthetic
Measured: 1 week post-op
Post-Operative Infection
Post-operative infection requiring topical or systemic antibiotics
Measured: 1 week post-op
Post-Operative Bleeding
Post-operative bleeding requiring surgical exploration/revision or hematoma evacuation
Measured: 1 week post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Oct 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion14 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for LidocaineStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Richard J. MacKay Endowment Fund, Benefactor Life Members' Research Grant, The Ottawa Hospital Division of Dermatology
- Responsible party
- Sponsor
- Investigators
- Jillian A Macdonald, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871478
- Sponsor's protocol ID
- #20160131
- Status last verified
- Jun 2020
- First submitted
- 1 Mar 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10319823Firoz 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.
PubMed 20542176Tetzlaff 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.
PubMed 10935008Koay 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.
PubMed 11860425Christensen 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.
PubMed 23866780Kaurich 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.
PubMed 9477866Markovic 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.
PubMed 17052624Su 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.
PubMed 24428507Thomson 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.
PubMed 16874214Yilmaz 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.
PubMed 19145998
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Local Anesthetics in Mohs Surgery
- ClinicalTrials.gov ID
- NCT03871478
- Acronym / sponsor ID
- #20160131
- Conditions
- Lidocaine, Bupivacaine, Mohs Surgery, Anesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Richard J. MacKay Endowment Fund, Benefactor Life Members' Research Grant, The Ottawa Hospital Division of Dermatology
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 14 Jun 2021 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
This study should take three months to complete and the results should be known in about 6 months.
ASSIGNMENT TO A GROUP If you decide to participate then you will be "randomized" into one of the groups described below. Randomization means that you are put into a group by chance (like flipping a coin). There is no way to predict which group you will be assigned to. You will have a one in three chance of being placed in either group. Neither you, the study staff, nor the study doctors can choose what group you will be in.
You will not know which group you are in, but the study doctor and study staff will.
WHAT IS THE STUDY INTERVENTION? Group 1: Lidocaine alone If you are randomized to this group you will receive lidocaine as your local anesthetic.
Group 2: Bupivacaine alone If you are randomized to this group you will receive bupivacaine as your local anesthetic.
Group 3: Lidocaine and bupivacaine used in combination If you are randomized to this group you will receive both lidocaine and bupivacaine used in combination during your procedure. First you will receive injections of lidocaine and then immediately afterwards you will receive injections of bupivacaine. Roughly equal volumes of lidocaine and bupivacaine will be used and the investigators expect the overall volume of local anesthetic (compared with group 1 and 2) that will be injected will be similar. The investigators expect the total number of needle pokes to be similar.
WHAT ELSE DO I NEED TO KNOW ABOUT THE STUDY INTERVENTION? All of the study interventions are considered standard of care for the use of local anesthetics in Mohs procedure. Local practices for using anesthetics are center dependent.
If you have side effects while you are on this study, the study doctor may make changes to the intervention.
If you require greater than three levels during your Mohs procedure, your data will be collected but will be excluded from the main study analysis. Patients requiring greater than three levels during their Mohs procedure are excluded because they often require more complex skin reconstruction surgery which can be more painful afterwards. The vast majority of patients undergoing Mohs surgery require one to three levels and it is these patients that the investigators are hoping to apply the results of our study to.
QUESTIONNAIRES As part of the study, you will be required to complete the same short questionnaire a total of nine times. This questionnaire will only be done by participants in this study.
The questionnaire will be completed at The Mohs Clinic just prior to your surgery and you will complete the questionnaire at home after your surgery at various time points (at 2, 4, 6, 8, 12, 24, 36 and 72 hours post surgery). The purpose of the questionnaire is assess the level of your surgical/incisional pain after Mohs surgery and enquire about any additional pain medications that you have taken after the surgery. It will take approximately 2 minutes to complete the questionnaire You will be asked to bring all of the completed questionnaires with you when you return to the Mohs Clinic for your follow-up visit one the investigatorsek after your surgery.
The information you provide is for research purposes only. You can choose not to ansthe investigatorsr questions if you wish.
Even though you may have provided information on a questionnaire, these responses will not be reviethe investigatorsd promptly by your health care team. If you wish them to know this information please bring it to their attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineBuffered lidocaine 1% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage |
| Bupivacaine | Active comparator | Drug: BupivacaineBupivacaine 0.5% with epinephrine 1:200,000 Injected at the start of every Mohs excision stage |
| Lidocaine and Bupivacaine | Active comparator | Drug: Lidocaine and BupivacaineBuffered 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Confirmed diagnosis of non-melanoma skin cancer
- Written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineSee Arm Description | Drug | Lidocaine |
| BupivacaineSee Arm Description | Drug | Bupivacaine |
| Lidocaine and BupivacaineSee Arm Description | Drug | Lidocaine and Bupivacaine |
Primary outcome
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).
3 secondary outcomes
Adverse Event
Time frame: 1 week post-op
Post-Operative Infection
Time frame: 1 week post-op
Post-Operative Bleeding
Time frame: 1 week post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 10319823Bouloux 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.
- Results publication: PubMed 20542176Firoz 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.
- Results publication: PubMed 10935008Tetzlaff 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.
- Results publication: PubMed 11860425Koay 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.
- Results publication: PubMed 23866780Christensen 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.
- Results publication: PubMed 9477866Kaurich 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.
- Results publication: PubMed 17052624Markovic 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.
- Results publication: PubMed 24428507Su 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.
- Results publication: PubMed 16874214Thomson 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.
- Results publication: PubMed 19145998Yilmaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jillian A Macdonald, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Bupivacaine and Lidocaine and Bupivacaine in people with Lidocaine and Bupivacaine, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jillian A Macdonald, MD (6137388400 ext. 81645, jimacdonald@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker FACES Pain Rating Scale (time frame: 2, 4, 6, 8, 12, 24, 36, and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871478, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.