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

Complex Regional Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01954888
• Other study ID #: 13054
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 2019

Study information

• Verified date: February 2020
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature		thirty minutes after block
Secondary	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