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

NCT01612364 | Unknown Phase 3 DMC

• 1 other identifier: 5138 - 1805142/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Complex Regional Pain Syndrome I of Upper Limb

Keywords

CRPS I

Outcome Measures

Primary Outcomes (1)

• Analgesia after block

  Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.

  1 month

Secondary Outcomes (1)

• analgesia quality of life

  1 year

Study Arms (2)

thoracic sympathetic block

EXPERIMENTAL

Sympathetic block of upper limb via thoracic vertebra T3

Procedure: thoracic sympathetic block

control block

ACTIVE COMPARATOR

Same medication used in experimental group, but in dorsal subcutaneous

Procedure: thoracic sympathetic block

Interventions

thoracic sympathetic block 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%

Also known as: T2-T3 thoracic sympathetic block, T3 sympathetic block, T2-T3 thoracic dorsal sympathetic block, thoracic sympathetic ganglion block

control block; thoracic sympathetic block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Study Officials

• Roberto O Rocha, MD

  Hospital das Clinicas Faculty of Medicine University Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto O Rocha, MD

CONTACT

551182668553; contato@drrobertorocha.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 5, 2012
• Study Start: January 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

BR (1)