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WithdrawnNCT03316066Updated Feb 24, 2020

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

An interventional study of stellate ganglion block with ropivacaine 0.2% 5 mL and stellate ganglion block wit ropivacaine 0.2% 2 mL in Complex Regional Pain Syndromes, sponsored by Maisonneuve-Rosemont Hospital. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-24.

Sponsored by Maisonneuve-Rosemont Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Not able to recruit enough patients

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Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Complex Regional Pain Syndromes

Keywords

  • Stellate Ganglion
  • Local Anesthetic
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In context

Complex Regional Pain Syndromes

206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.

Browse Complex Regional Pain Syndromes studies →

Lead sponsor

Maisonneuve-Rosemont Hospital is the lead sponsor of 73 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient refusal
  • to the stellate ganglion block procedure such as coagulopathy, anticoagulants or anti therapy other than aspirin, systemic or injection site infection, important neck deformity (post-radiotherapy or surgery, etc.), severe , 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 ( \< 30 ml/min)
  • Inability to understand à verbal numeric pain score scale after careful explanations
  • Inability to consent
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group 5

    stellate ganglion block with ropivacaine 0.2% 5 mL

    Procedure: stellate ganglion block with ropivacaine 0.2% 5 mL

  • Active comparator
    Group 2

    stellate ganglion block wit ropivacaine 0.2% 2 mL

    Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mL

Interventions

  • Procedurestellate 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.

  • Procedurestellate 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours after the stellate ganglion block

Secondary outcomes

  1. 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.

    Time frame: 7 days after the stellate ganglion block

  2. 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.

    Time frame: 14 days after the stellate ganglion block

  3. 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.

    Time frame: 1 hour after the procedure

  4. 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.

    Time frame: 1 hour after the procedure

  5. Occurrence of dysphagia after a stellate ganglion block

    Patients describing having dysphagia after the stellate ganglion block

    Time frame: 1 hour after the procedure

  6. Occurrence of hoarseness after a stellate ganglion block

    patients describing having hoarseness after a stellate ganglion block

    Time frame: 1 hour after the procedure

  7. Occurrence of foreign body sensation after a stellate ganglion block

    patients describing having a foreign body sensation after the stellate ganglion block

    Time frame: 1h after the procedure

  8. Occurrence of dyspnea after a stellate ganglion block

    patients describing having dyspnea after a stellate ganglion block

    Time frame: 1h after the procedure

  9. Occurrence of ipsilateral arm weakness after a stellate ganglion block

    patients describing having ipsilateral arm weakness after a stellate ganglion block

    Time frame: 1h after the procedure

Other outcomes

  1. Occurrence of seizure during a stellate ganglion block

    patient having seizure

    Time frame: within 30 minutes of performing the stellate ganglion block

  2. Occurrence of hematoma after a stellate ganglion block

    physician or patient identifying a neck hematoma

    Time frame: During the first 7 days after the procedure

  3. Occurrence of pneumothorax after a stellate ganglion block

    physician diagnosing a pneumothorax

    Time frame: During the first 7 days after the procedure

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Feb 2020, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2016
First posted
Oct 20, 2017
StartActual
Oct 20, 2018
Primary completionActual
Feb 21, 2020
CompletionActual
Feb 21, 2020
Last update
Feb 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03316066
Lead sponsor
Maisonneuve-Rosemont Hospital
Responsible party
Veronique Brulotte (MD, MSc, FRCPC, Maisonneuve-Rosemont Hospital) — Principal investigator
First posted
Oct 20, 2017
Start date
Oct 20, 2018
Primary completion
Feb 21, 2020
Completion
Feb 21, 2020
Last update
Feb 24, 2020

Study contacts

Veronique Brulotte, MD
principal investigator · Maisonneuve-Rosemont Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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