| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
|
| 介入1/Interventions/Control_1 |
痛みの治療としての神経ブロックを行う。超音波ガイド下やCTガイド下で画像ガイド下に行う。介入の回数は1回から数回である。神経ブロックを行う日数は1回あたり1日である。 |
nerve block for pain therapy, under imaging guidance of ultrasound or CT, times of intervention: 1 ~ several times, one nerve block in a day, |
| 介入2/Interventions/Control_2 |
|
|
| 介入3/Interventions/Control_3 |
|
|
| 介入4/Interventions/Control_4 |
|
|
| 介入5/Interventions/Control_5 |
|
|
| 介入6/Interventions/Control_6 |
|
|
| 介入7/Interventions/Control_7 |
|
|
| 介入8/Interventions/Control_8 |
|
|
| 介入9/Interventions/Control_9 |
|
|
| 介入10/Interventions/Control_10 |
|
|
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
https://www.dovepress.com/journal-of-pain-research-journal |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
9 |
| 主な結果/Results |
Elevation in temperature: by over 1 (sympathetic block, n = 62) and by less than 1 (non-sympathetic block, n = 27). Finger blood flow decreased significantly just after a change in posture after SGB in both groups. In the sympathetic block group, the ratio of finger blood flow in the long sitting position / supine position with a change in posture significantly increased after SGB compared with before SGB (before SGB: range 0.09-0.94, median 0.53, after SGB: range 0.33-1.2, median 0.89, p < 0.0001). |
Evation in temperature: by over 1 (sympathetic block, n = 62) and by less than 1 (non-sympathetic block, n = 27). Finger blood flow decreased significantly just after a change in posture after SGB in both groups. In the sympathetic block group, the ratio of finger blood flow in the long sitting position / supine position with a change in posture significantly increased after SGB compared with before SGB (before SGB: range 0.09-0.94, median 0.53, after SGB: range 0.33-1.2, median 0.89, p < 0.0001). |
| 主な結果入力日/Results date posted |
|
| 結果掲載遅延/Results Delayed |
|
| 結果遅延理由/Results Delay Reason |
|
|
| 最初の試験結果の出版日/Date of the first journal publication of results |
|
| 参加者背景/Baseline Characteristics |
Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication. |
Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication. |
| 参加者の流れ/Participant flow |
Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication. |
Nine patients, 5 males and 4 females, aged 44-80 years (mean age 62.3 years, standard deviation 13.3), required treatment by stellate ganglion block. The diagnoses were herpes zoster pain in seven of the patients, tinnitus in one patient, and upper limb pain in one patient. The patients had no history of orthostatic intolerance, such as orthostatic hypotension and related diseases affecting the sympathetic nervous system, or disordered circulation in the upper limb, and were not on prescription vasoactive, cardiac or sweating related medication. |
| 有害事象/Adverse events |
none |
none |
| 評価項目/Outcome measures |
1. Horner’s sign. After SGB, we checked for the presence of myosis, ptosis and enophthalmos. This was assessed to identify successful block of the cervical sympathetic trunk.
2. Presence of brachial nerve block, to exclude sympathetic block in the upper limb due to inadvertent brachial plexus block. In patients in whom it did occur, a significant increase in blood flow to the fingers of the blocked hand was observed throughout the period of brachial plexus anesthesia.4 We checked the presence of brachial nerve block or not.
3. Skin temperature of the thumb on the blocked side by thermography before SGB and 20 min after SGB. An indicator of sympathetic block in the upper limb is elevated skin temperature of over 1 relative to before SGB.5
4. Blood flow in the ball of the thumb on the SGB side. This was measured using a laser blood flow meter (Laser Doppler ALF 21D, ADMEDIC Co. Ltd., Japan) in the supine position and immediately after changing to the long sitting position (the lowest finger blood flow), before SGB and 20 min after SGB.
|
1. Horner sign. After SGB, we checked for the presence of myosis, ptosis and enophthalmos. This was assessed to identify successful block of the cervical sympathetic trunk.
2. Presence of brachial nerve block, to exclude sympathetic block in the upper limb due to inadvertent brachial plexus block. In patients in whom it did occur, a significant increase in blood flow to the fingers of the blocked hand was observed throughout the period of brachial plexus anesthesia.4 We checked the presence of brachial nerve block or not.
3. Skin temperature of the thumb on the blocked side by thermography before SGB and 20 min after SGB. An indicator of sympathetic block in the upper limb is elevated skin temperature of over 1 relative to before SGB.
4. Blood flow in the ball of the thumb on the SGB side. This was measured using a laser blood flow meter (Laser Doppler ALF 21D, ADMEDIC Co. Ltd., Japan) in the supine position and immediately after changing to the long sitting position (the lowest finger blood flow), before SGB and 20 min after SGB.
|
| 個別症例データ共有計画/Plan to share IPD |
|
|
| 個別症例データ共有計画の詳細/IPD sharing Plan description |
|
|
UMIN-CTR 臨床試験登録情報の閲覧