Complex Regional Pain Syndromes
Conditions
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.
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).
Interventions
PROCEDUREBlind 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).
PROCEDUREUltrasound-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).
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature | thirty minutes after block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of pain | 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). |
Countries
Canada
Outcome results
None listed