- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866899
Axillary Block or Wide-awake Local Anesthesia for Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries
Comparison of Axillary Block Regional Anesthesia and Wide-awake Local Anesthesia No Tourniquet (WALANT) Anesthesia in the Incidence of Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Altındağ
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Ankara, Altındağ, Turkey, 06230
- Ankara University Medical Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with and operated on for Dupuytren contracture (DC),
- Patients diagnosed with and operated on for De Quervain tenosynovitis (DQS),
- Patients diagnosed with and operated on for carpal tunnel syndrome (CTS),
- Patients diagnosed with and operated on for trigger finger (TF)
Exclusion Criteria:
- Patients operated under general anesthesia,
- Patients operated with other types of regional anesthesia (eg: supraclavicular block),
- Patients operated with other types of local anesthesia (only prilocaine or bupivacaine)
- Patients less than 3 months follow up
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
WALANT
Patients operated under WALANT (wide awake local anesthesia without tourniquet)
|
All of the patients were operated for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF).
The study is two center study, one center has the routine of RAAB (regional anesthesia with axillary block) and the other has the routine of WALANT (wide awake local anesthesia no tourniquet) for the mentioned surgeries.
Wide awake local anesthesia no tourniquet
|
|
RAAB
Patients operated under RAAB (regional anesthesia with axillary block)
|
All of the patients were operated for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF).
The study is two center study, one center has the routine of RAAB (regional anesthesia with axillary block) and the other has the routine of WALANT (wide awake local anesthesia no tourniquet) for the mentioned surgeries.
Regional anesthesia with axillary block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CRPS severity score (CSS)
Time Frame: Postoperative first month
|
CRPS: Complex regional pain sydrome The CRPS Severity Score is a composite measure derived from multiple clinical findings, summed to provide a single score ranging from 0 to 16. The ccore is based on four major clinical domains, with each domain contributing 0 to 4 points, leading to a total possible score of 16 points.
|
Postoperative first month
|
|
CRPS severity score (CSS)
Time Frame: Postoperative third month
|
CRPS: Complex regional pain sydrome The CRPS Severity Score is a composite measure derived from multiple clinical findings, summed to provide a single score ranging from 0 to 16. The ccore is based on four major clinical domains, with each domain contributing 0 to 4 points, leading to a total possible score of 16 points.
|
Postoperative third month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flare reaction
Time Frame: Postoperative first month
|
Presence of Flare reaction. Evaluation based on Evans' criteria 0 - no reaction
|
Postoperative first month
|
|
Flare reaction
Time Frame: Postoperative third month
|
Presence of Flare reaction. Evaluation based on Evans' criteria 0 - no reaction
|
Postoperative third month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Axillary block vs Walant
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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