Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSeoul National University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 19-80 years

Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity

11-point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity

Temperature increase at diagnostic thoracic sympathetic ganglion block

Disqualifiers

Refusal of the patient

Vascular disease at upper extremity

previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)

coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Local anestheticsActive comparator 1 intervention
Group B: Botulinum toxin AExperimental treatment 1 intervention

Trial outcomes

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

Time frame
4 weeks after procedure

Secondary outcomes

1

The changes in average pain intensity in 12weeks

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

Time frame
12 weeks after procedure
2

The changes in maximum pain intensity

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

Time frame
4 and 12 weeks after procedure
3

The changes in pain related to procedure

Inter- and intra-group comparison of the change in procedure-related 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable)

Time frame
30 minutes after the procedure
4

The change in the temperature difference

the change in the relative temperature difference on the blocked palm compared with the contralateral palm

Time frame
30 minutes, 4 and 12 weeks after the procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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