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

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.

Study Overview

• Status: Terminated
• Conditions: Complex Regional Pain Syndromes
• Intervention / Treatment: Procedure: Blind technique; Procedure: Ultrasound-guided technique

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T2M4
      • Maisonneuve-Rosemont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blind technique; Stellate ganglion block using the anterior paratracheal approach using surface landmarks.	Procedure: Blind technique; A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approaches (blind and ultrasound-guided).
Active Comparator: Ultrasound-guided technique; Stellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level.	Procedure: Ultrasound-guided technique; A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approach (blind and ultrasound-guided).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature	thirty minutes after block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 of the block to one week after the block

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of pain	The severity of the pain will be evaluated before the block and each day after the block for one week using a numeric rating scale (0-10).	Immediately and each day after the block until one week after the block

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Veronique Brulotte, MD, MSC, FRCPC, Maisonneuve-Rosemont Hospital

Publications and helpful links

General Publications

• Bhatia A, Flamer D, Peng PW. Evaluation of sonoanatomy relevant to performing stellate ganglion blocks using anterior and lateral simulated approaches: an observational study. Can J Anaesth. 2012 Nov;59(11):1040-7. doi: 10.1007/s12630-012-9779-4. Epub 2012 Sep 6.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 7, 2013

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: 13054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO