Complex Regional Pain Syndromes
Conditions
Keywords
Stellate Ganglion, Local Anesthetic
Brief summary
The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local anesthetics used in stellate ganglion blocks for the treatment of complex regional pain syndrome of the arm.
Detailed description
To evaluate if 2ml of 0.2% ropivacaine is less effective in decreasing pain scores by more than 50% when compared to 5ml of 0.2% ropivacaine. To evaluate if 2ml of 0.2% ropivacaine is causes less side effects when compared to 5ml after a stellate ganglion block.
Interventions
PROCEDUREstellate ganglion block with ropivacaine 0.2% 5 mL
Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.
PROCEDUREstellate ganglion block wit ropivacaine 0.2% 2 mL
Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of complex regional pain syndrome of the arm according to the Budapest criteria and having already received a minimum of 3 stellate ganglion blocks. Only patients having received a minimum of 3 stellate ganglion blocks will be included since it is expected to have a progressive and sustained decrease in pain scores during the first 3 blocks. * ASA 1 to 3 included
Exclusion criteria
* Patient refusal * Contra-indications to the stellate ganglion block procedure such as coagulopathy, anticoagulants or anti platelet therapy other than aspirin, systemic or injection site infection, important neck deformity (post-radiotherapy or surgery, etc.), severe chronic obstructive pulmonary disease, contralateral diaphragm paralysis or contralateral pneumonectomy * Allergy to local anesthetics * Concomitant pain syndrome other than complex regional pain syndrome of the arm * Liver or kidney failure (CrCl \< 30 ml/min) * Inability to understand à verbal numeric pain score scale after careful explanations * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 24 hours after the stellate ganglion block | Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of ipsilateral arm weakness after a stellate ganglion block | 1h after the procedure | patients describing having ipsilateral arm weakness after a stellate ganglion block |
| Occurrence of hoarseness after a stellate ganglion block | 1 hour after the procedure | patients describing having hoarseness after a stellate ganglion block |
| Occurrence of foreign body sensation after a stellate ganglion block | 1h after the procedure | patients describing having a foreign body sensation after the stellate ganglion block |
| Occurrence of dyspnea after a stellate ganglion block | 1h after the procedure | patients describing having dyspnea after a stellate ganglion block |
| Pain score | 7 days after the stellate ganglion block | Evaluate the efficiency of stellate ganglion block in decreasing pain scores 7 days after the procedure using a verbal numeric pain rating scale. |
| Temperature increase in the ipsilateral arm | 1 hour after the procedure | Evaluate the efficiency of stellate ganglion block on the increase in temperature of the ipsilateral arm using an infrared thermometer. The cutaneous temperature will be measured in order to determine the proportion of patients in each group reaching an increase of \>1.5 C in the ipsilateral arm. |
| Horner Syndrome | 1 hour after the procedure | Evaluate the efficiency of stellate ganglion block to produce an ipsilateral Horner Syndrome as defined by a ptosis and miosis. Evaluate the proportion of patients in each group presenting an ipsilateral Horner syndrome. |
| Occurrence of dysphagia after a stellate ganglion block | 1 hour after the procedure | Patients describing having dysphagia after the stellate ganglion block |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of hematoma after a stellate ganglion block | During the first 7 days after the procedure | physician or patient identifying a neck hematoma |
| Occurrence of pneumothorax after a stellate ganglion block | During the first 7 days after the procedure | physician diagnosing a pneumothorax |
| Occurrence of seizure during a stellate ganglion block | within 30 minutes of performing the stellate ganglion block | patient having seizure |
Outcome results
None listed