Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm

Complex Regional Pain Syndromes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03316066
• Other study ID #: Maisonneuve RH
• Status: Withdrawn
• Phase: N/A
• Start date: October 20, 2018
• Est. completion date: February 21, 2020

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Ganglion Cysts
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

Procedure:
• stellate 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.
• stellate 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of seizure during a stellate ganglion block	patient having seizure	within 30 minutes of performing the stellate ganglion block
Other	Occurrence of hematoma after a stellate ganglion block	physician or patient identifying a neck hematoma	During the first 7 days after the procedure
Other	Occurrence of pneumothorax after a stellate ganglion block	physician diagnosing a pneumothorax	During the first 7 days after the procedure
Primary	Pain score	Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.	24 hours after the stellate ganglion block
Secondary	Pain score	Evaluate the efficiency of stellate ganglion block in decreasing pain scores 7 days after the procedure using a verbal numeric pain rating scale.	7 days after the stellate ganglion block
Secondary	Pain score	Evaluate the efficiency of stellate ganglion block in decreasing pain scores 14 days after the procedure using a verbal numeric pain rating scale.	14 days after the stellate ganglion block
Secondary	Temperature increase in the ipsilateral arm	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.	1 hour after the procedure
Secondary	Horner Syndrome	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.	1 hour after the procedure
Secondary	Occurrence of dysphagia after a stellate ganglion block	Patients describing having dysphagia after the stellate ganglion block	1 hour after the procedure
Secondary	Occurrence of hoarseness after a stellate ganglion block	patients describing having hoarseness after a stellate ganglion block	1 hour after the procedure
Secondary	Occurrence of foreign body sensation after a stellate ganglion block	patients describing having a foreign body sensation after the stellate ganglion block	1h after the procedure
Secondary	Occurrence of dyspnea after a stellate ganglion block	patients describing having dyspnea after a stellate ganglion block	1h after the procedure
Secondary	Occurrence of ipsilateral arm weakness after a stellate ganglion block	patients describing having ipsilateral arm weakness after a stellate ganglion block	1h after the procedure