Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

N/ATerminatedNCT01954888

Maisonneuve-Rosemont Hospital3 enrolled

Overview

The first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome. The second purpose of this study is to determine the safest approach and to compare the safety profiles of the two approaches.

To evaluate whether the ultrasound guided approach is more effective than the blind technique in producing a greater than 1.5 degree Celsius rise in ipsilateral arm temperature after a stellate ganglion block. Blocks will both be performed with 10 mL of xylocaine/bupivacaine. Secondary outcomes will be the impact of the approach (blind vs ultrasound) on pain reduction, horner syndrome, side effects (hoarseness, dysphagia, pharyngeal discomfort) and complications (blood aspiration, intravascular injection).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Complex Regional Pain Syndromes

Interventions

Blind techniquePROCEDURE

A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approaches (blind and ultrasound-guided).

Ultrasound-guided techniquePROCEDURE

A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approach (blind and ultrasound-guided).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 to 80 years * Patients with a new or known diagnosis of complex regional pain syndrome (according to the criteria of Budapest) at the upper extremity Exclusion Criteria: * Refusal of a patient * Coagulopathy * Systemic infection or local infection at the needle injection site * Major deformation at the level of the neck (radiotherapy, surgery, etc. ) * Concomitant chronic pain syndrome * Post-pneumonectomy on the controlateral side * Severe hepatic impairment or severe renal impairment (Clcr under 30 ml/min) * Known allergy to local anesthetics of amide type * Inability to understand a numeric pain scale

Locations (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature

Time frame: thirty minutes after block

Secondary Outcomes

Complications

Seizure, loss of consciousness with apnea, hematoma, recurrent laryngeal nerve injury, phrenic nerve paralysis, pneumothorax, weakness of the ipsilateral upper limb, foreign body sensation

Time frame: Time of the block to one week after the block

Data from ClinicalTrials.gov

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