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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Withdrawn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
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring Stellate Ganglion, Local Anesthetic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 22, 2016
    Last Updated
    February 21, 2020
    Sponsor
    Maisonneuve-Rosemont Hospital
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    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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