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

NCT01954888 | Terminated DMC

• 1 other identifier: 13054
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

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

  thirty minutes after block

Secondary Outcomes (1)

• Complications

  Time of the block to one week after the block

Other Outcomes (1)

• Severity of pain

  Immediately and each day after the block until one week after the block

Study Arms (2)

Blind technique

ACTIVE COMPARATOR

Stellate ganglion block using the anterior paratracheal approach using surface landmarks.

Procedure: Blind technique

Ultrasound-guided technique

ACTIVE COMPARATOR

Stellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level.

Procedure: Ultrasound-guided technique

Interventions

Blind technique PROCEDURE

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

Blind technique

Ultrasound-guided technique PROCEDURE

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

Ultrasound-guided technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 22956268 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Veronique Brulotte, MD, MSC, FRCPC

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Impact of the ultrasound-guided approach on the efficiency and safety of the stellate ganglion block in chronic pain

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 7, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)