CRPSNCT06866899
Axillary Block or Wide-awake Local Anesthesia for Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries
An observational study of CRPS and Walant, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (CRPS) when pain is present. This study compares flare and CRPS incidence following hand surgeries performed under regional anesthesia with axillary block (RAAB) and WALANT (Wide-Awake… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRPS, Walant, Axillary Block
- What is being tested?
- Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF), Regional Anesthesia and Local Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jul 2024
- Phase
- Observational
- 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
Study population: atients diagnosed with and operated on for Dupuytren contracture (DC), De Quervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical Faculty
Ankara, Altındağ, 06230
About this study
Official title: 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
Flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (CRPS) when pain is present. This study compares flare and CRPS incidence following hand surgeries performed under regional anesthesia with axillary block (RAAB) and WALANT (Wide-Awake Local Anesthesia No Tourniquet).
Read the detailed description
This two-center prospective study included patients undergoing Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), and trigger finger (TF) surgeries under RAAB or WALANT. Diagnostic criteria for flare and CRPS (pain, weakness, scar issues, erythema, and swelling) were assessed, and comorbidities were noted. The incidence of flare reactions and CRPS was compared for RAAB and WALANT.
- Conditions
- CRPS, Walant, Axillary Block
- Being tested
- Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF), Regional Anesthesia, Local Anesthesia
- Keywords
- CRPS, flare reaction, WALANT, axillary block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)Procedure or surgery
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 AnesthesiaProcedure or surgery
Regional anesthesia with axillary block
Local AnesthesiaProcedure or surgery
Wide awake local anesthesia no tourniquet
| Study group | Role | What they receive |
|---|---|---|
| WALANT | Patients operated under WALANT (wide awake local anesthesia without tourniquet) Receives: Procedure: Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF); Procedure: Local Anesthesia | |
| RAAB | Patients operated under RAAB (regional anesthesia with axillary block) Receives: Procedure: Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF); Procedure: Regional Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRPS severity score (CSS)
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.
- Sensory Symptoms (0-4 points) Allodynia (Pain due to a stimulus that does not normally provoke pain) Hyperalgesia (Increased pain response to a normally painful stimulus)
- Vasomotor Symptoms (0-4 points) Temperature asymmetry (≥1°C difference between affected and unaffected limb) Skin color changes (Mottled, red, cyanotic, or pale discoloration)
- Sudomotor / Edema Symptoms (0-4 points) Abnormal sweating (Hyperhidrosis or hypohidrosis) Edema (Swelling) in the affected area
- Motor / Trophic Symptoms (0-4 points) Motor dysfunction (Weakness, dystonia, tremors) Trophic changes (Altered nail growth, skin texture changes, or abnormal hair growth)
Measured: Postoperative first month
CRPS severity score (CSS)
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.
- Sensory Symptoms (0-4 points) Allodynia (Pain due to a stimulus that does not normally provoke pain) Hyperalgesia (Increased pain response to a normally painful stimulus)
- Vasomotor Symptoms (0-4 points) Temperature asymmetry (≥1°C difference between affected and unaffected limb) Skin color changes (Mottled, red, cyanotic, or pale discoloration)
- Sudomotor / Edema Symptoms (0-4 points) Abnormal sweating (Hyperhidrosis or hypohidrosis) Edema (Swelling) in the affected area
- Motor / Trophic Symptoms (0-4 points) Motor dysfunction (Weakness, dystonia, tremors) Trophic changes (Altered nail growth, skin texture changes, or abnormal hair growth)
Measured: Postoperative third month
Secondary outcomes (2)
Flare reaction
Presence of Flare reaction. Evaluation based on Evans' criteria 0 - no reaction
- redness, stiffness, edema at the operation site
- symptoms beyond operation site
Measured: Postoperative first month
Flare reaction
Presence of Flare reaction. Evaluation based on Evans' criteria 0 - no reaction
- redness, stiffness, edema at the operation site
- symptoms beyond operation site
Measured: Postoperative third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPSStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Dursun Savran, MD, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866899
- Sponsor's protocol ID
- Axillary block vs Walant
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Some individual personal data are pictures with identifiable elements of the patient.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06866899
- Acronym / sponsor ID
- Axillary block vs Walant
- Conditions
- CRPS, Walant, Axillary Block
- Keywords
- CRPS, flare reaction, WALANT, axillary block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 Mar 2025 (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.
Flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (CRPS) when pain is present. This study compares flare and CRPS incidence following hand surgeries performed under regional anesthesia with axillary block (RAAB) and WALANT (Wide-Awake Local Anesthesia No Tourniquet).
Detailed description
This two-center prospective study included patients undergoing Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), and trigger finger (TF) surgeries under RAAB or WALANT. Diagnostic criteria for flare and CRPS (pain, weakness, scar issues, erythema, and swelling) were assessed, and comorbidities were noted. The incidence of flare reactions and CRPS was compared for RAAB and WALANT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WALANT | – | Procedure: Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF), Procedure: Local AnesthesiaPatients operated under WALANT (wide awake local anesthesia without tourniquet) |
| RAAB | – | Procedure: Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF), Procedure: Regional AnesthesiaPatients operated under RAAB (regional anesthesia with axillary block) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- atients diagnosed with and operated on for Dupuytren contracture (DC), De Quervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)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. | Procedure or surgery | RAAB, WALANT |
| Regional AnesthesiaRegional anesthesia with axillary block | Procedure or surgery | RAAB |
| Local AnesthesiaWide awake local anesthesia no tourniquet | Procedure or surgery | WALANT |
Primary outcome
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. 1. Sensory Symptoms (0-4 points) Allodynia (Pain due to a stimulus that does not normally provoke pain) Hyperalgesia (Increased pain response to a normally painful stimulus) 2. Vasomotor Symptoms (0-4 points) Temperature asymmetry (≥1°C difference between affected and unaffected limb) Skin color changes (Mottled, red, cyanotic, or pale discoloration) 3. Sudomotor / Edema Symptoms (0-4 points) Abnormal sweating (Hyperhidrosis or hypohidrosis) Edema (Swelling) in the affected area 4. Motor / Trophic Symptoms (0-4 points) Motor dysfunction (Weakness, dystonia, tremors) Trophic changes (Altered nail growth, skin texture changes, or abnormal hair growth)
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. 1. Sensory Symptoms (0-4 points) Allodynia (Pain due to a stimulus that does not normally provoke pain) Hyperalgesia (Increased pain response to a normally painful stimulus) 2. Vasomotor Symptoms (0-4 points) Temperature asymmetry (≥1°C difference between affected and unaffected limb) Skin color changes (Mottled, red, cyanotic, or pale discoloration) 3. Sudomotor / Edema Symptoms (0-4 points) Abnormal sweating (Hyperhidrosis or hypohidrosis) Edema (Swelling) in the affected area 4. Motor / Trophic Symptoms (0-4 points) Motor dysfunction (Weakness, dystonia, tremors) Trophic changes (Altered nail growth, skin texture changes, or abnormal hair growth)
2 secondary outcomes
Flare reaction
Time frame: Postoperative first month
Flare reaction
Time frame: Postoperative third month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided. Some individual personal data are pictures with identifiable elements of the patient.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRPS and Walant, run by Ankara University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 10 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CRPS severity score (CSS) (time frame: Postoperative first month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.