Axillary Block or Wide-awake Local Anesthesia for Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries

March 6, 2025 updated by: Merve Dursun Savran, MD, Ankara University

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).

Study Overview

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 Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Altındağ
      • Ankara, Altındağ, Turkey, 06230
        • Ankara University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

atients diagnosed with and operated on for Dupuytren contracture (DC), De Quervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

  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)
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.

  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)
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

  1. redness, stiffness, edema at the operation site
  2. symptoms beyond operation site
Postoperative first month
Flare reaction
Time Frame: Postoperative third month

Presence of Flare reaction. Evaluation based on Evans' criteria 0 - no reaction

  1. redness, stiffness, edema at the operation site
  2. symptoms beyond operation site
Postoperative third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Some individual personal data are pictures with identifiable elements of the patient.

Drug and device information, study documents

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

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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