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Clinical trial

Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers

ID
Name
REB22-1157
Description
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.
Trial arms
Trial start
2022-11-10
Estimated PCD
2025-01-01
Trial end
2025-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
Arms:
Receiving Local Anesthetic Injection
Other names:
Saline
Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
Arms:
Receiving Local Anesthetic Injection
Other names:
Xylocaine, Lignocaine
Size
155
Primary endpoint
Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ]
5 minutes post-injection
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 155, 'type': 'ESTIMATED'}}
Updated at
2023-11-30

1 organization

2 products

3 indications

Organization
University of Calgary
Product
0.9% Sodium Chloride
Indication
Ehlers-Danlos Syndrome
Indication
Anesthesia
Indication
Local
Product
Lidocaine