Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Primary Purpose
Ehlers-Danlos Syndrome, Anesthesia, Local
Status
Active
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
0.9% Sodium Chloride Injection
Lidocaine Injection 2%
Sponsored by
About this trial
This is an interventional other trial for Ehlers-Danlos Syndrome focused on measuring Ehlers-Danlos Syndrome, Local Anesthesia Resistance
Eligibility Criteria
Inclusion Criteria: EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria EDS patients with genetically proven non-hypermobile EDS Healthy participants, no EDS Able and willing to provide informed consent Exclusion Criteria: Known allergy to Lidocaine Unable to provide informed consent
Sites / Locations
- Cardiovascular Autonomic Research Lab, University of Calgary
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Receiving Local Anesthetic Injection
Arm Description
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Outcomes
Primary Outcome Measures
Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ]
Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control [non-injected] region) to 3 (same or worse than the control region).
Secondary Outcome Measures
Delta Pain Scores Lidocaine at 30 min
Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control [non-injected] region) to 3 (same or worse than the control region).
Full Information
NCT ID
NCT05603741
First Posted
October 24, 2022
Last Updated
March 6, 2023
Sponsor
University of Calgary
Collaborators
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05603741
Brief Title
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Official Title
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Vanderbilt University Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Local anesthetic resistance is commonly reported by patients with EDS. However, there are no objective data on the occurrence of local anesthetic resistance in EDS patients and in healthy volunteers. The investigators propose to collect such objective data on the frequency of drug resistance and whether any problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.
Detailed Description
There was a prior large online questionnaire to better understand the issues around local anesthetic resistance. By November 2018, 933 EDS patients (total 1059 respondents) completed the survey, 99.2% of which had previously received local anesthetics. Among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of respondents without EDS reported a similar problem. These data suggests that local anesthetic resistance might be more prevalent in patients with EDS than in the general population. If these findings are true, then this might have significant implications for the appropriate management of these patients during minor surgery and dental procedures.
This study aims to assess the frequency and related issues around local anesthetic resistance in EDS patients, including whether the problem is a lack of analgesia or a timing effect (short duration of action or delayed onset of action), and whether the problem relates only to some local anesthetics or whether there is a problem with the whole class of local anesthetics. This study is completing data originally collected during a 2019 EDS conference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ehlers-Danlos Syndrome, Anesthesia, Local
Keywords
Ehlers-Danlos Syndrome, Local Anesthesia Resistance
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Receiving Local Anesthetic Injection
Arm Type
Other
Arm Description
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride Injection
Other Intervention Name(s)
Saline
Intervention Description
All participants will be injected subcutaneously with a single 0.5ml dose
Intervention Type
Drug
Intervention Name(s)
Lidocaine Injection 2%
Other Intervention Name(s)
Xylocaine, Lignocaine
Intervention Description
All participants will be injected subcutaneously with a single 0.5ml dose
Primary Outcome Measure Information:
Title
Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ]
Description
Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control [non-injected] region) to 3 (same or worse than the control region).
Time Frame
5 minutes post-injection
Secondary Outcome Measure Information:
Title
Delta Pain Scores Lidocaine at 30 min
Description
Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control [non-injected] region) to 3 (same or worse than the control region).
Time Frame
30 minutes post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria
EDS patients with genetically proven non-hypermobile EDS
Healthy participants, no EDS
Able and willing to provide informed consent
Exclusion Criteria:
Known allergy to Lidocaine
Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Autonomic Research Lab, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
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