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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-11-30

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).

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Detailed Description

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Conditions

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Complex Regional Pain Syndrome I of Upper Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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thoracic sympathetic block

Sympathetic block of upper limb via thoracic vertebra T3

Group Type EXPERIMENTAL

thoracic sympathetic block

Intervention Type PROCEDURE

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%

control block

Same medication used in experimental group, but in dorsal subcutaneous

Group Type ACTIVE_COMPARATOR

thoracic sympathetic block

Intervention Type PROCEDURE

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%

Interventions

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thoracic sympathetic block

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%

Intervention Type PROCEDURE

Other Intervention Names

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T2-T3 thoracic sympathetic block T3 sympathetic block T2-T3 thoracic dorsal sympathetic block thoracic sympathetic ganglion block

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No