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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Complex Regional Pain Syndromes
• Intervention / Treatment: Procedure: stellate ganglion block with ropivacaine 0.2% 5 mL; Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mL

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 5; stellate ganglion block with ropivacaine 0.2% 5 mL	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.
Active Comparator: Group 2; stellate ganglion block wit ropivacaine 0.2% 2 mL	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Occurrence of dysphagia after a stellate ganglion block	Patients describing having dysphagia after the stellate ganglion block	1 hour after the procedure
Occurrence of hoarseness after a stellate ganglion block	patients describing having hoarseness after a stellate ganglion block	1 hour after the procedure
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
Occurrence of dyspnea after a stellate ganglion block	patients describing having dyspnea after a stellate ganglion block	1h after the procedure
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of seizure during a stellate ganglion block	patient having seizure	within 30 minutes of performing the stellate ganglion block
Occurrence of hematoma after a stellate ganglion block	physician or patient identifying a neck hematoma	During the first 7 days after the procedure
Occurrence of pneumothorax after a stellate ganglion block	physician diagnosing a pneumothorax	During the first 7 days after the procedure

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: veronique Brulotte, MD, Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2018
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): February 21, 2020

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Local Anesthetic; Stellate Ganglion
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Disease; Cysts; Connective Tissue Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mucinoses; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Ganglion Cysts; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Maisonneuve RH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No