Complex Regional Pain SyndromesNCT01954888
Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain
A study testing Blind technique and Ultrasound-guided technique in people with Complex Regional Pain Syndromes, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome. 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?
- Blind technique and Ultrasound-guided technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Oct 2019
- 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 aged 18 to 80 years
- Patients with a new or known diagnosis of complex regional pain syndrome (according to the criteria of Budapest) at the upper extremity
Who cannot join
- Refusal of a patient
- Coagulopathy
- Systemic infection or local infection at the needle injection site
- Major deformation at the level of the neck (radiotherapy, surgery, etc. )
- Concomitant chronic pain syndrome
- Post-pneumonectomy on the controlateral side
Show all 9Show fewer
- Severe hepatic impairment or severe renal impairment (Clcr under 30 ml/min)
- Known allergy to local anesthetics of amide type
- Inability to understand a numeric pain scale
Trial locations and contacts
1 site in 1 country.
About this study
The first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome.
The second purpose of this study is to determine the safest approach and to compare the safety profiles of the two approaches.
Read the detailed description
To evaluate whether the ultrasound guided approach is more effective than the blind technique in producing a greater than 1.5 degree Celsius rise in ipsilateral arm temperature after a stellate ganglion block.
Blocks will both be performed with 10 mL of xylocaine/bupivacaine. Secondary outcomes will be the impact of the approach (blind vs ultrasound) on pain reduction, horner syndrome, side effects (hoarseness, dysphagia, pharyngeal discomfort) and complications (blood aspiration, intravascular injection).
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Blind technique, Ultrasound-guided technique
- 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.
Blind techniqueProcedure or surgery
A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approaches (blind and ultrasound-guided).
Ultrasound-guided techniqueProcedure or surgery
A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approach (blind and ultrasound-guided).
| Study group | Role | What they receive |
|---|---|---|
| Blind technique | Active comparator | Stellate ganglion block using the anterior paratracheal approach using surface landmarks. Receives: Procedure: Blind technique |
| Ultrasound-guided technique | Active comparator | Stellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level. Receives: Procedure: Ultrasound-guided technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature
Measured: thirty minutes after block
Secondary outcomes (1)
Complications
Seizure, loss of consciousness with apnea, hematoma, recurrent laryngeal nerve injury, phrenic nerve paralysis, pneumothorax, weakness of the ipsilateral upper limb, foreign body sensation
Measured: Time of the block to one week after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3 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, MSC, FRCPC, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954888
- Sponsor's protocol ID
- 13054
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2013
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bhatia A, Flamer D, Peng PW. Evaluation of sonoanatomy relevant to performing stellate ganglion blocks using anterior and lateral simulated approaches: an observational study. Can J Anaesth. 2012 Nov;59(11):1040-7. doi: 10.1007/s12630-012-9779-4. Epub 2012 Sep 6.
PubMed 22956268
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
- Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain
- ClinicalTrials.gov ID
- NCT01954888
- Acronym / sponsor ID
- 13054
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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 first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome.
The second purpose of this study is to determine the safest approach and to compare the safety profiles of the two approaches.
Detailed description
To evaluate whether the ultrasound guided approach is more effective than the blind technique in producing a greater than 1.5 degree Celsius rise in ipsilateral arm temperature after a stellate ganglion block.
Blocks will both be performed with 10 mL of xylocaine/bupivacaine. Secondary outcomes will be the impact of the approach (blind vs ultrasound) on pain reduction, horner syndrome, side effects (hoarseness, dysphagia, pharyngeal discomfort) and complications (blood aspiration, intravascular injection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind technique | Active comparator | Procedure: Blind techniqueStellate ganglion block using the anterior paratracheal approach using surface landmarks. |
| Ultrasound-guided technique | Active comparator | Procedure: Ultrasound-guided techniqueStellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level. |
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 aged 18 to 80 years
- Patients with a new or known diagnosis of complex regional pain syndrome (according to the criteria of Budapest) at the upper extremity
Key exclusion criteria (9 listed)
- Refusal of a patient
- Coagulopathy
- Systemic infection or local infection at the needle injection site
- Major deformation at the level of the neck (radiotherapy, surgery, etc. )
- Concomitant chronic pain syndrome
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 |
|---|---|---|
| Blind techniqueA mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approaches (blind and ultrasound-guided). | Procedure or surgery | Blind technique |
| Ultrasound-guided techniqueA mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approach (blind and ultrasound-guided). | Procedure or surgery | Ultrasound-guided technique |
Primary outcome
proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature
Time frame: thirty minutes after block
1 secondary outcome
Complications
Time frame: Time of the block to one week after the block
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background: PubMed 22956268Bhatia A, Flamer D, Peng PW. Evaluation of sonoanatomy relevant to performing stellate ganglion blocks using anterior and lateral simulated approaches: an observational study. Can J Anaesth. 2012 Nov;59(11):1040-7. doi: 10.1007/s12630-012-9779-4. Epub 2012 Sep 6.
- 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, MSC, FRCPC principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blind technique and Ultrasound-guided technique in people with Complex Regional Pain Syndromes, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 9 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: stopped early, 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.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early. Results are not available in the source record.
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?
proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature (time frame: thirty minutes after block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01954888, which also lists 1 linked publication.
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.