Skip to main content
OpenTrials
Completed

NCT Number: NCT04876989

The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Chronic Post Surgical Pain Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Phantom Limb Phantom Limb Pain Post-Traumatic Neuralgia Postherpetic Neuralgia Postoperative Complications Signs and Symptoms

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

US-SGB

Procedure

Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)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 US-SGB group.

US-TPVB

Procedure

Well trained pain physician performs all the ultrasound(US)-guided thoracic paravertebral block(SGB)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 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 US-TPVB group.

Primary outcomes

  1. Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand

    Time frame: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

    Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.

Secondary outcomes

  1. Difference of temperature change (°C) between ipsilateral hand and contralateral hand

    Time frame: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

    Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.

  2. Severity of pain

    Time frame: Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

    The severity of the pain will be evaluated before the block and 20 minutes, 1 week and 4 weeks after the block using an 11-pointed NRS (numerical rating scale) pain score.

  3. Patient global impression change (PGIC)

    Time frame: Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

    The PGIC will be evaluated 20 minutes, 1 week and 4 weeks after the block using a 5-point Likert scale.

  4. Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire

    Time frame: Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

    Check the CISS before the procedure and 4 weeks after the procedure.

  5. Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound

    Time frame: Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

    The blood flow velocity in the ipsilateral brachial artery will be measured before the block and 20 minutes after the block using a Doppler mode ultrasound device.

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Collaborators

  • SMG-SNU Boramae Medical Center

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 7, 2021
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.