Clinical trial NCT04876989: The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block
Official title: The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Postherpetic Neuralgia
Phantom Limb Pain
Chronic Post Surgical Pain
Post-Traumatic Neuralgia
Neuropathic Pain
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2021-05-07
Enrollment: 69
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.

Detailed description: Well-trained pain physicians performs all US-guided stellate ganglion block(SGB)s or US-guided thoracic paravertebrl block(TPVB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure.

For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the SGB group. Syringes are prepared by one nurse who do not involved in other steps of this study.

For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the TPVB group. Syringes are prepared by one nurse who do not involved in other steps of this study.

Temperature measurement is conducted 2 times (before US-guided SGB or TPVB and after 20 minutes) at both hands by one person who's not involved in other measuring in the study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of complex regional pain syndrome
* Clinical diagnosis of postherpetic neuralgia
* Clinical diagnosis of phantom limb pain
* Clinical diagnosis of chronic post-surgical pain
* Clinical diagnosis of post-traumatic pain syndrome
* Upper extremity pain lasting more than 3 months

Patients with a new or known diagnosis of chronic neuropathic pain lasting more than 3 months in the upper extremity

Exclusion Criteria:

* Refusal of a patient
* Any vascular disease in the upper extremities
* Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. -thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis)
* Coagulopathy
* Systemic infection or local infection at the needle injection site
* Major deformation at the level of the neck (radiotherapy, surgery, etc.)
* Known allergy to local anesthetics of amide type
* Inability to understand a numeric rating pain scale (cognitive dysfunction)
* Patients whose palm temperature on the ipsilateral side is ≥ 36.5℃ in the thermography before the procedure

Primary outcomes:
measure: Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
timeFrame: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Secondary outcomes:
measure: Difference of temperature change (°C) between ipsilateral hand and contralateral hand
timeFrame: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
measure: Severity of pain
timeFrame: Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
measure: Patient global impression change (PGIC)
timeFrame: Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
measure: Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
timeFrame: Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
measure: Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound
timeFrame: Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Moon Jee, MD, PhD
role: STUDY_DIRECTOR
affiliation: SMG-SNU Boramae Medical Center
name: Jeongsoo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: