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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954888
Recruitment Status : Terminated
First Posted : October 7, 2013
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Veronique Brulotte, Maisonneuve-Rosemont Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Procedure: Blind technique Procedure: Ultrasound-guided technique Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain
Study Start Date : September 2013
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature [ Time Frame: thirty minutes after block ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: 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


Other Outcome Measures:
  1. Severity of pain [ Time Frame: Immediately and each day after the block until one week after the block ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954888


Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Veronique Brulotte, MD, MSC, FRCPC Maisonneuve-Rosemont Hospital
More Information
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Publications:

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Responsible Party: Veronique Brulotte, Impact of the ultrasound-guided approach on the efficiency and safety of the stellate ganglion block in chronic pain, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01954888    
Other Study ID Numbers: 13054
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Chronic Pain
Pain
Neurologic Manifestations
 Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases