Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A

NCT06470581 | Not Yet Recruiting DMC

• 1 other identifier: 2402-117-1516
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• The changes in average pain intensity in 4weeks

  Comparison between groups of the average change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours

  4 weeks after procedure

Secondary Outcomes (10)

• The changes in average pain intensity in 12weeks

  12 weeks after procedure

• The changes in maximum pain intensity

  4 and 12 weeks after procedure

• The changes in pain related to procedure

  30 minutes after the procedure

• The change in the temperature difference

  30 minutes, 4 and 12 weeks after the procedure

• Blood flow velosity

  30 minutes, 4 and 12 weeks after the procedure

Study Arms (2)

Local anesthetics

ACTIVE COMPARATOR

Total volume of 0.375% ropivacaine 3 mL will be injected in phase 2.

Drug: Botulinum toxin A

Botulinum toxin A

EXPERIMENTAL

Total volume of BTX-A 75U in normal saline 3ml will be injected in phase 2.

Drug: Botulinum toxin A

Interventions

Botulinum toxin A DRUG

Patients were assigned 1:1 to a control group using only local anesthetics (Group A) and a BTX-A group (Group B). In Phase 1, the needle is inserted near the vertebrae T3 under fluoroscopic guidance. An 1 ml of non-ionized contrast medium is injected to evaluate the diffusion pattern, and 3ml of 0.75% ropivacaine is injected. After identifying a temperature increase in the ipsilateral palm within 20 min in the operating room with the prone position, 3 ml of 0.375% ropivacaine and botulinum toxin type A 75 IU mixed with 3 ml of non-preserved saline solution are injected in the patients in the control and botulinum toxin groups, respectively.

Botulinum toxin A; Local anesthetics

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 19-80 years
• Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity
• point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity
• Temperature increase at diagnostic thoracic sympathetic ganglion block
• Patients taking medication stably (without change in dosage/recipe) for more than 4 weeks prior to administration

You may not qualify if:

• Refusal of the patient
• Vascular disease at upper extremity
• previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)
• coagulopathy
• systemic infection or local infection at thoracic puncture site
• significant deformity at thoracic spine
• neoplasm
• known allergic reaction with amide type local anesthetics
• cognitive dysfunction (not understanding of numerical-rating-scale)
• known allergic reaction with botulinum toxin
• pregnant or feeding women
• If the patient has participated in another clinical trial within 30 days before screening, or if passed no longer than 5-fold half-life of the clinical trial drug of the participating clinical trial

Sponsors & Collaborators

• Seoul National University: lead

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion: April 25, 2026
• Study Completion (Estimated): April 25, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06