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

Not Applicable

Terminated

• Conditions: Complex Regional Pain Syndromes
• Interventions: Procedure: Blind technique; Procedure: Ultrasound-guided technique

• Registration Number: NCT01954888
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-07
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blind technique	Blind technique	Stellate ganglion block using the anterior paratracheal approach using surface landmarks.
Ultrasound-guided technique	Ultrasound-guided technique	Stellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level.

Primary Outcome Measures

Name	Time	Method
proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature	thirty minutes after block

Secondary Outcome Measures

Name	Time	Method
Complications	Time of the block to one week after the block	Seizure, loss of consciousness with apnea, hematoma, recurrent laryngeal nerve injury, phrenic nerve paralysis, pneumothorax, weakness of the ipsilateral upper limb, foreign body sensation

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada