Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm
Primary Purpose
Complex Regional Pain Syndromes
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stellate ganglion block with ropivacaine 0.2% 5 mL
stellate ganglion block wit ropivacaine 0.2% 2 mL
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring Stellate Ganglion, Local Anesthetic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 5
Group 2
Arm Description
stellate ganglion block with ropivacaine 0.2% 5 mL
stellate ganglion block wit ropivacaine 0.2% 2 mL
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Occurrence of dysphagia after a stellate ganglion block
Patients describing having dysphagia after the stellate ganglion block
Occurrence of hoarseness after a stellate ganglion block
patients describing having hoarseness after a stellate ganglion block
Occurrence of foreign body sensation after a stellate ganglion block
patients describing having a foreign body sensation after the stellate ganglion block
Occurrence of dyspnea after a stellate ganglion block
patients describing having dyspnea after a stellate ganglion block
Occurrence of ipsilateral arm weakness after a stellate ganglion block
patients describing having ipsilateral arm weakness after a stellate ganglion block
Full Information
NCT ID
NCT03316066
First Posted
November 22, 2016
Last Updated
February 21, 2020
Sponsor
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03316066
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Not able to recruit enough patients
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
Keywords
Stellate Ganglion, Local Anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 5
Arm Type
Experimental
Arm Description
stellate ganglion block with ropivacaine 0.2% 5 mL
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
stellate ganglion block wit ropivacaine 0.2% 2 mL
Intervention Type
Procedure
Intervention Name(s)
stellate ganglion block with ropivacaine 0.2% 5 mL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
stellate ganglion block wit ropivacaine 0.2% 2 mL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score
Description
Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.
Time Frame
24 hours after the stellate ganglion block
Secondary Outcome Measure Information:
Title
Pain score
Description
Evaluate the efficiency of stellate ganglion block in decreasing pain scores 7 days after the procedure using a verbal numeric pain rating scale.
Time Frame
7 days after the stellate ganglion block
Title
Pain score
Description
Evaluate the efficiency of stellate ganglion block in decreasing pain scores 14 days after the procedure using a verbal numeric pain rating scale.
Time Frame
14 days after the stellate ganglion block
Title
Temperature increase in the ipsilateral arm
Description
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.
Time Frame
1 hour after the procedure
Title
Horner Syndrome
Description
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.
Time Frame
1 hour after the procedure
Title
Occurrence of dysphagia after a stellate ganglion block
Description
Patients describing having dysphagia after the stellate ganglion block
Time Frame
1 hour after the procedure
Title
Occurrence of hoarseness after a stellate ganglion block
Description
patients describing having hoarseness after a stellate ganglion block
Time Frame
1 hour after the procedure
Title
Occurrence of foreign body sensation after a stellate ganglion block
Description
patients describing having a foreign body sensation after the stellate ganglion block
Time Frame
1h after the procedure
Title
Occurrence of dyspnea after a stellate ganglion block
Description
patients describing having dyspnea after a stellate ganglion block
Time Frame
1h after the procedure
Title
Occurrence of ipsilateral arm weakness after a stellate ganglion block
Description
patients describing having ipsilateral arm weakness after a stellate ganglion block
Time Frame
1h after the procedure
Other Pre-specified Outcome Measures:
Title
Occurrence of seizure during a stellate ganglion block
Description
patient having seizure
Time Frame
within 30 minutes of performing the stellate ganglion block
Title
Occurrence of hematoma after a stellate ganglion block
Description
physician or patient identifying a neck hematoma
Time Frame
During the first 7 days after the procedure
Title
Occurrence of pneumothorax after a stellate ganglion block
Description
physician diagnosing a pneumothorax
Time Frame
During the first 7 days after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique Brulotte, MD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm
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