Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm

Not Applicable

Withdrawn

• Conditions: Complex Regional Pain Syndromes
• Interventions: Procedure: stellate ganglion block with ropivacaine 0.2% 5 mL; Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mL

• Registration Number: NCT03316066
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local anesthetics used in stellate ganglion blocks for the treatment of complex regional pain syndrome of the arm.

Detailed Description

To evaluate if 2ml of 0.2% ropivacaine is less effective in decreasing pain scores by more than 50% when compared to 5ml of 0.2% ropivacaine. To evaluate if 2ml of 0.2% ropivacaine is causes less side effects when compared to 5ml after a stellate ganglion block.

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-20
• Study Start: 2018-10-20
• Status Verified: 2020-02
• Primary Completion: 2020-02-21
• Study Completion: 2020-02-21
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with a diagnosis of complex regional pain syndrome of the arm according to the Budapest criteria and having already received a minimum of 3 stellate ganglion blocks. Only patients having received a minimum of 3 stellate ganglion blocks will be included since it is expected to have a progressive and sustained decrease in pain scores during the first 3 blocks.
• ASA 1 to 3 included

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Exclusion Criteria

• Patient refusal
• Contra-indications to the stellate ganglion block procedure such as coagulopathy, anticoagulants or anti platelet therapy other than aspirin, systemic or injection site infection, important neck deformity (post-radiotherapy or surgery, etc.), severe chronic obstructive pulmonary disease, contralateral diaphragm paralysis or contralateral pneumonectomy
• Allergy to local anesthetics
• Concomitant pain syndrome other than complex regional pain syndrome of the arm
• Liver or kidney failure (CrCl < 30 ml/min)
• Inability to understand à verbal numeric pain score scale after careful explanations
• Inability to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 5	stellate ganglion block with ropivacaine 0.2% 5 mL	stellate ganglion block with ropivacaine 0.2% 5 mL
Group 2	stellate ganglion block wit ropivacaine 0.2% 2 mL	stellate ganglion block wit ropivacaine 0.2% 2 mL

Primary Outcome Measures

Name	Time	Method
Pain score	24 hours after the stellate ganglion block	Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.

Secondary Outcome Measures

Name	Time	Method
Pain score	14 days after the stellate ganglion block	Evaluate the efficiency of stellate ganglion block in decreasing pain scores 14 days after the procedure using a verbal numeric pain rating scale.
Temperature increase in the ipsilateral arm	1 hour after the procedure	Evaluate the efficiency of stellate ganglion block on the increase in temperature of the ipsilateral arm using an infrared thermometer. The cutaneous temperature will be measured in order to determine the proportion of patients in each group reaching an increase of \>1.5 C in the ipsilateral arm.
Occurrence of dysphagia after a stellate ganglion block	1 hour after the procedure	Patients describing having dysphagia after the stellate ganglion block
Occurrence of dyspnea after a stellate ganglion block	1h after the procedure	patients describing having dyspnea after a stellate ganglion block
Horner Syndrome	1 hour after the procedure	Evaluate the efficiency of stellate ganglion block to produce an ipsilateral Horner Syndrome as defined by a ptosis and miosis. Evaluate the proportion of patients in each group presenting an ipsilateral Horner syndrome.
Occurrence of hoarseness after a stellate ganglion block	1 hour after the procedure	patients describing having hoarseness after a stellate ganglion block
Occurrence of foreign body sensation after a stellate ganglion block	1h after the procedure	patients describing having a foreign body sensation after the stellate ganglion block
Occurrence of ipsilateral arm weakness after a stellate ganglion block	1h after the procedure	patients describing having ipsilateral arm weakness after a stellate ganglion block