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NCT Number: NCT06866899

Axillary Block or Wide-awake Local Anesthesia for 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).

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Key information

Conditions

CRPS Axillary Block Walant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Medical Faculty

Ankara, Altındağ, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)

Procedure

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

Procedure

Regional anesthesia with axillary block

local anesthesia

Procedure

Wide awake local anesthesia no tourniquet

Primary outcomes

  1. 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.

    • 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)

  2. 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.

    • 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)

Secondary outcomes

  1. Flare reaction

    Time frame: Postoperative first month

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

    • redness, stiffness, edema at the operation site
    • symptoms beyond operation site

  2. Flare reaction

    Time frame: Postoperative third month

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

    • redness, stiffness, edema at the operation site
    • symptoms beyond operation site

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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