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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Withdrawn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

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

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

Studies a U.S. FDA-regulated Device Product

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

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

Time Frame

1 hour after the procedure

Title

Horner Syndrome

Description

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

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

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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