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

Maisonneuve-Rosemont Hospital

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Complex Regional Pain Syndromes

Interventions

stellate ganglion block with ropivacaine 0.2% 5 mLPROCEDURE

Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.

stellate ganglion block wit ropivacaine 0.2% 2 mLPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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

Time frame: 24 hours after the stellate ganglion block

Secondary Outcomes

Pain score

Evaluate the efficiency of stellate ganglion block in decreasing pain scores 7 days after the procedure using a verbal numeric pain rating scale.

Time frame: 7 days after the stellate ganglion block

Pain score

Evaluate the efficiency of stellate ganglion block in decreasing pain scores 14 days after the procedure using a verbal numeric pain rating scale.

Time frame: 14 days after the stellate ganglion block

Temperature increase in the ipsilateral arm

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.

Time frame: 1 hour after the procedure

Horner Syndrome

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.

Time frame: 1 hour after the procedure

Occurrence of dysphagia after a stellate ganglion block

Patients describing having dysphagia after the stellate ganglion block

Time frame: 1 hour after the procedure

Data from ClinicalTrials.gov

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