RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

Study Overview
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Brief Summary
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This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).

Official Title
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Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

Conditions
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Complex Regional Pain Syndrome I of Upper Limb

Intervention / Treatment
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* Procedure: thoracic sympathetic block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complex regional pain syndrome (IASP, 1994) involving an upper limb; Pain scores in excess of five visual analog scale (VAS); Poor outcome to treatment (less than 50% reduction in VAS scores) - Exclusion Criteria: History of severe brain injury, epilepsy and stroke Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique Severe systemic disease Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated Refusal to participate or not initial adherence to orientations Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thoracic sympathetic block<br>Sympathetic block of upper limb via thoracic vertebra T3 | Procedure: thoracic sympathetic block<br>* Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%<br>* Other names: thoracic sympathetic ganglion block;|
| Active Comparator: control block<br>Same medication used in experimental group, but in dorsal subcutaneous | Procedure: thoracic sympathetic block<br>* Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%<br>* Other names: thoracic sympathetic ganglion block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia after block | Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia quality of life |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRPS I