Clinical trial NCT03316066: Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm
Official title: Comparison of Two Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for the Treatment of Complex Regional Pain Syndrome of the Arm
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: Stellate Ganglion
Local Anesthetic
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: 24 hours after the stellate ganglion block
Secondary outcomes:
measure: Pain score
timeFrame: 7 days after the stellate ganglion block
measure: Pain score
timeFrame: 14 days after the stellate ganglion block
measure: Temperature increase in the ipsilateral arm
timeFrame: 1 hour after the procedure
measure: Horner Syndrome
timeFrame: 1 hour after the procedure
measure: Occurrence of dysphagia after a stellate ganglion block
timeFrame: 1 hour after the procedure
measure: Occurrence of hoarseness after a stellate ganglion block
timeFrame: 1 hour after the procedure
measure: Occurrence of foreign body sensation after a stellate ganglion block
timeFrame: 1h after the procedure
measure: Occurrence of dyspnea after a stellate ganglion block
timeFrame: 1h after the procedure
measure: Occurrence of ipsilateral arm weakness after a stellate ganglion block
timeFrame: 1h after the procedure
Other outcomes:
measure: Occurrence of seizure during a stellate ganglion block
timeFrame: within 30 minutes of performing the stellate ganglion block
measure: Occurrence of hematoma after a stellate ganglion block
timeFrame: During the first 7 days after the procedure
measure: Occurrence of pneumothorax after a stellate ganglion block
timeFrame: During the first 7 days after the procedure
Locations:
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Veronique Brulotte, MD
role: PRINCIPAL_INVESTIGATOR
References: