Complex Regional Pain SyndromesNCT03316066
Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm
A study testing stellate ganglion block with ropivacaine 0.2% 5 mL and stellate ganglion block wit ropivacaine 0.2% 2 mL in people with Complex Regional Pain Syndromes, run by Maisonneuve-Rosemont Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- stellate ganglion block with ropivacaine 0.2% 5 mL and stellate ganglion block wit ropivacaine 0.2% 2 mL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- stellate ganglion block with ropivacaine 0.2% 5 mL, stellate ganglion block wit ropivacaine 0.2% 2 mL
- Keywords
- Stellate Ganglion, Local Anesthetic
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion block with ropivacaine 0.2% 5 mLProcedure or surgery
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.
stellate ganglion block wit ropivacaine 0.2% 2 mLProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 5 | Experimental | stellate ganglion block with ropivacaine 0.2% 5 mL Receives: Procedure: stellate ganglion block with ropivacaine 0.2% 5 mL |
| Group 2 | Active comparator | stellate ganglion block wit ropivacaine 0.2% 2 mL Receives: Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after the stellate ganglion block
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour after the procedure
Occurrence of dysphagia after a stellate ganglion block
Patients describing having dysphagia after the stellate ganglion block
Measured: 1 hour after the procedure
Occurrence of hoarseness after a stellate ganglion block
patients describing having hoarseness after a stellate ganglion block
Measured: 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
Measured: 1h after the procedure
Occurrence of dyspnea after a stellate ganglion block
patients describing having dyspnea after a stellate ganglion block
Measured: 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
Measured: 1h after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start20 Oct 2018
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Why it stopped: Not able to recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Brulotte, Maisonneuve-Rosemont Hospital
- Investigators
- Veronique Brulotte, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316066
- Sponsor's protocol ID
- Maisonneuve RH
- Status last verified
- Feb 2020
- First submitted
- 22 Nov 2016
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03316066
- Acronym / sponsor ID
- Maisonneuve RH
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- Stellate Ganglion, Local Anesthetic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to recruit enough patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 5 | Experimental | Procedure: stellate ganglion block with ropivacaine 0.2% 5 mLstellate ganglion block with ropivacaine 0.2% 5 mL |
| Group 2 | Active comparator | Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mLstellate ganglion block wit ropivacaine 0.2% 2 mL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stellate ganglion block with ropivacaine 0.2% 5 mLEach 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. | Procedure or surgery | Group 5 |
| stellate ganglion block wit ropivacaine 0.2% 2 mLEach 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. | Procedure or surgery | Group 2 |
Primary outcome
Pain score
Time frame: 24 hours after the stellate ganglion block
Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.
9 secondary outcomes
Pain score
Time frame: 7 days after the stellate ganglion block
Pain score
Time frame: 14 days after the stellate ganglion block
Temperature increase in the ipsilateral arm
Time frame: 1 hour after the procedure
Horner Syndrome
Time frame: 1 hour after the procedure
Occurrence of dysphagia after a stellate ganglion block
Time frame: 1 hour after the procedure
Occurrence of hoarseness after a stellate ganglion block
Time frame: 1 hour after the procedure
Occurrence of foreign body sensation after a stellate ganglion block
Time frame: 1h after the procedure
Occurrence of dyspnea after a stellate ganglion block
Time frame: 1h after the procedure
Occurrence of ipsilateral arm weakness after a stellate ganglion block
Time frame: 1h after the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Brulotte, MD principal investigator
Maisonneuve-Rosemont Hospital
Questions about this trial
What is this clinical trial studying?
A study testing stellate ganglion block with ropivacaine 0.2% 5 mL and stellate ganglion block wit ropivacaine 0.2% 2 mL in people with Complex Regional Pain Syndromes, run by Maisonneuve-Rosemont Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 24 hours after the stellate ganglion block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.