Ehlers-Danlos SyndromePhase 4NCT05603741
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
A Phase 4 study testing 0.9% Sodium Chloride Injection and Lidocaine Injection 2% in people with Ehlers-Danlos Syndrome and Anesthesia, Local, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ehlers-Danlos Syndrome, Anesthesia, Local
- What is being tested?
- 0.9% Sodium Chloride Injection and Lidocaine Injection 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2022to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known allergy to Lidocaine
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiovascular Autonomic Research Lab, University of Calgary
Calgary, Alberta, T2N 4Z6
About this study
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.
Read the 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.
- Conditions
- Ehlers-Danlos Syndrome, Anesthesia, Local
- Being tested
- 0.9% Sodium Chloride Injection, Lidocaine Injection 2%
- Keywords
- Ehlers-Danlos Syndrome, Local Anesthesia Resistance
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride InjectionDrug
Also called Saline
All participants will be injected subcutaneously with a single 0.5ml dose
Lidocaine Injection 2%Drug
Also called Xylocaine, Lignocaine
All participants will be injected subcutaneously with a single 0.5ml dose
| Study group | Role | What they receive |
|---|---|---|
| Receiving Local Anesthetic Injection | Other | Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome Receives: Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 minutes post-injection
Secondary outcomes (1)
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).
Measured: 30 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start10 Nov 2022
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603741
- Sponsor's protocol ID
- REB22-1157
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bourne KM, Thai S, Lei LY, Siddiqui T, Black B, Peltier A, Paranjape S, Shibao CA, Biaggioni I, Diedrich A, Gamboa A, Okamoto L, Sheldon RS, Raj SR. Patients with Ehlers-Danlos syndrome experience reduced effectiveness of lidocaine local anesthetic: a randomized cross-over clinical trial. Reg Anesth Pain Med. 2026 Mar 3:rapm-2025-107416. doi: 10.1136/rapm-2025-107416. Online ahead of print.
PubMed 41775498
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05603741
- Acronym / sponsor ID
- REB22-1157
- Conditions
- Ehlers-Danlos Syndrome, Anesthesia, Local
- Keywords
- Ehlers-Danlos Syndrome, Local Anesthesia Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Nov 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving Local Anesthetic Injection | Other | Drug: 0.9% Sodium Chloride Injection, Drug: Lidocaine Injection 2%Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Known allergy to Lidocaine
- Unable to provide informed consent
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 |
|---|---|---|
| 0.9% Sodium Chloride InjectionAlso: SalineAll participants will be injected subcutaneously with a single 0.5ml dose | Drug | Receiving Local Anesthetic Injection |
| Lidocaine Injection 2%Also: Xylocaine, LignocaineAll participants will be injected subcutaneously with a single 0.5ml dose | Drug | Receiving Local Anesthetic Injection |
Primary outcome
Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ]
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).
1 secondary outcome
Delta Pain Scores Lidocaine at 30 min
Time frame: 30 minutes post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 41775498Bourne KM, Thai S, Lei LY, Siddiqui T, Black B, Peltier A, Paranjape S, Shibao CA, Biaggioni I, Diedrich A, Gamboa A, Okamoto L, Sheldon RS, Raj SR. Patients with Ehlers-Danlos syndrome experience reduced effectiveness of lidocaine local anesthetic: a randomized cross-over clinical trial. Reg Anesth Pain Med. 2026 Mar 3:rapm-2025-107416. doi: 10.1136/rapm-2025-107416. Online ahead of print.
- 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.
Satish R Raj, MD MSCI principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9% Sodium Chloride Injection and Lidocaine Injection 2% in people with Ehlers-Danlos Syndrome and Anesthesia, Local, run by University of Calgary 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ] (time frame: 5 minutes post-injection). 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 NCT05603741, which also lists 1 linked publication.
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 18 Dec 2024.