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Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

Primary Purpose

Complex Regional Pain Syndromes

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Blind technique

Ultrasound-guided technique

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Blind technique

Ultrasound-guided technique

Arm Description

Stellate ganglion block using the anterior paratracheal approach using surface landmarks.

Stellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level.

Outcomes

Primary Outcome Measures

proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01954888

First Posted

September 26, 2013

Last Updated

February 21, 2020

Sponsor

Maisonneuve-Rosemont Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01954888

Brief Title

Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

Official Title

Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Study Start Date

September 2013 (undefined)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complex Regional Pain Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blind technique

Arm Type

Active Comparator

Arm Description

Stellate ganglion block using the anterior paratracheal approach using surface landmarks.

Arm Title

Ultrasound-guided technique

Arm Type

Active Comparator

Arm Description

Stellate ganglion block using the ultrasound-guided lateral approach at the sixth cervical vertebral level.

Intervention Type

Procedure

Intervention Name(s)

Blind technique

Intervention Description

A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approaches (blind and ultrasound-guided).

Intervention Type

Procedure

Intervention Name(s)

Ultrasound-guided technique

Intervention Description

A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approach (blind and ultrasound-guided).

Primary Outcome Measure Information:

Title

proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature

Time Frame

thirty minutes after block

Secondary Outcome Measure Information:

Title

Complications

Description

Seizure, loss of consciousness with apnea, hematoma, recurrent laryngeal nerve injury, phrenic nerve paralysis, pneumothorax, weakness of the ipsilateral upper limb, foreign body sensation

Time Frame

Time of the block to one week after the block

Other Pre-specified Outcome Measures:

Title

Severity of pain

Description

The severity of the pain will be evaluated before the block and each day after the block for one week using a numeric rating scale (0-10).

Time Frame

Immediately and each day after the block until one week after the block

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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronique Brulotte, MD, MSC, FRCPC

Organizational Affiliation

Maisonneuve-Rosemont Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maisonneuve-Rosemont Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T2M4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22956268

Citation

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.

Results Reference

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Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

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