Chronic Post Surgical Pain, Complex Regional Pain Syndromes, Neuropathic Pain, Phantom Limb Pain, Postherpetic Neuralgia, Post-Traumatic Neuralgia
Conditions
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.
Interventions
PROCEDUREUS-SGB
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.
PROCEDUREUS-TPVB
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.
Sponsors
SMG-SNU Boramae Medical Center
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference of temperature change (°C) between ipsilateral hand and contralateral hand | 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. |
| Severity of pain | 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. |
| Patient global impression change (PGIC) | 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. |
| Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire | 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. |
| Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound | 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. |
Countries
South Korea
Outcome results
None listed