RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
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ClinicalTrials.gov Identifier: NCT01612364 |
Recruitment Status
: Unknown
Verified June 2012 by Roberto O Rocha, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted
: June 5, 2012
Last Update Posted
: June 5, 2012
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Condition or disease | Intervention/treatment | Phase |
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Complex Regional Pain Syndrome I of Upper Limb | Procedure: thoracic sympathetic block | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb |
Study Start Date : | January 2010 |
Estimated Primary Completion Date : | November 2013 |
Estimated Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: thoracic sympathetic block
Sympathetic block of upper limb via thoracic vertebra T3
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Procedure: 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%
Other Names:
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Active Comparator: control block
Same medication used in experimental group, but in dorsal subcutaneous
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Procedure: 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%
Other Names:
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- Analgesia after block [ Time Frame: 1 month ]Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
- analgesia quality of life [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612364
Contact: Roberto O Rocha, MD | 551182668553 | contato@drrobertorocha.com.br |
Brazil | |
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo | Recruiting |
Sao Paulo, Brazil, 05403000 | |
Contact: Roberto O Rocha, MD 5511 82668553 contato@drrobertorocha.com.br | |
Principal Investigator: Roberto O Rocha, MD |
Principal Investigator: | Roberto O Rocha, MD | Hospital das Clinicas Faculty of Medicine University Sao Paulo |
Responsible Party: | Roberto O Rocha, MD, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01612364 History of Changes |
Other Study ID Numbers: |
5138 - 1805142/1 |
First Posted: | June 5, 2012 Key Record Dates |
Last Update Posted: | June 5, 2012 |
Last Verified: | June 2012 |
Keywords provided by Roberto O Rocha, University of Sao Paulo:
CRPS I |
Additional relevant MeSH terms:
Syndrome Somatoform Disorders Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Disease Pathologic Processes |
Mental Disorders Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |