Comparison of Two Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for the Treatment of Complex Regional Pain Syndrome of the Arm

Maisonneuve-Rosemont Hospital0 sitesOctober 20, 2018

ConditionsComplex Regional Pain Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Complex Regional Pain Syndromes
Sponsor: Maisonneuve-Rosemont Hospital
Primary Endpoint: Pain score
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 20, 2018

End Date

February 21, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Maisonneuve-Rosemont Hospital

Responsible Party

Principal Investigator

Veronique Brulotte

MD, MSc, FRCPC

Maisonneuve-Rosemont Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Pain score

Time Frame: 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 Outcomes

Pain score(14 days after the stellate ganglion block)
Temperature increase in the ipsilateral arm(1 hour after the procedure)
Occurrence of dysphagia after a stellate ganglion block(1 hour after the procedure)
Occurrence of dyspnea after a stellate ganglion block(1h after the procedure)
Horner Syndrome(1 hour after the procedure)
Occurrence of hoarseness after a stellate ganglion block(1 hour after the procedure)
Occurrence of foreign body sensation after a stellate ganglion block(1h after the procedure)
Occurrence of ipsilateral arm weakness after a stellate ganglion block(1h after the procedure)