Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470581
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-17
Brief Title:
Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A
Sponsor:
Seoul National University
Organization:
Seoul National University
Study Overview
Official Title:
Clinical Effect of Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A in Patients With Upper Extremity Complex Regional Pain Syndrome A Prospective Randomized Double-blind and Comparative Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient The temperature of the affected arm is often lower than that of the opposite side As a result of the procedure the patient may experience sympathetic pain relief such as coldness stinging numbness of the upper extremity If the procedure does not last long repetitive block or chemical neurolysis or radiofrequency thermocoagulation for the sympathetic ganglion is performed
However even though in rare cases chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion Therefore it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury
Recently it has been reported that botulinum toxin BTX has been successfully used for the treatment of pain disorders BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings Therefore the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity Therefore Botulinum toxin type A BTA is recommended for the treatment of migraine myofascial pain syndrome and neuropathic pain accompanied by allodynia This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized double-blind parallel group and comparative clinical trials
However even though in rare cases chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion Therefore it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury
Recently it has been reported that botulinum toxin BTX has been successfully used for the treatment of pain disorders BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings Therefore the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity Therefore Botulinum toxin type A BTA is recommended for the treatment of migraine myofascial pain syndrome and neuropathic pain accompanied by allodynia This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized double-blind parallel group and comparative clinical trials
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None