Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain
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|ClinicalTrials.gov Identifier: NCT01954888|
Recruitment Status : Terminated
First Posted : October 7, 2013
Last Update Posted : February 24, 2020
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|
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 (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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).
- proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature [ Time Frame: thirty minutes after block ]
- 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
- 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).
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
|Montreal, Quebec, Canada, H1T2M4|
|Principal Investigator:||Veronique Brulotte, MD, MSC, FRCPC||Maisonneuve-Rosemont Hospital|