Ultrasound Guided Ganglion Impar Block
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBaşakşehir Çam & Sakura City Hospital
About this trial
The aim of this study is to evaluate feasibility, reliability and short term effectiveness of ganglion impar block with ultrasound in patients with chronic coccygodinia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-65 years.
Coccydynia persisting for at least three months.
Being scheduled for a ganglion impar block in the pain medicine outpatient clinic.
Having inadequate response to medical and conservative treatments.
Disqualifiers
Local infection at the injection site.
Bleeding disorders or diseases and drugs that may cause bleeding diatesis (e.g. renal failure, liver failure, anticoagulant treatments)
History of allergic reaction to the medications to be used.
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound-guided ganglion impar block
Procedure/SurgeryThe procedure will be performed under sterile conditions and continuous monitoring. Using an ultrasound device with a 10-12 MHz linear probe, a 22G spinal needle will be advanced into the sacrococcygeal joint space using the out-of-plane technique. After confirming loss of resistance with a syringe containing normal saline as the needle exits the capsule anterior to the joint, approximately 1 mL of contrast medium will be injected. Anteroposterior (AP) and lateral fluoroscopic images will be obtained to verify the spread of the contrast agent. Once adequate contrast distribution is confirmed anterior to the coccyx on the lateral view, a mixture of dexamethasone and bupivacaine will be injected to complete the block. Procedures that cannot be completed or successfully visualized under ultrasound guidance will be finalized under fluoroscopic guidance.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Injection GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Injection accuracy
In all patients, the sacrococcygeal or transcoccygeal space will be identified under ultrasound guidance. A 22-gauge spinal needle will be advanced into the joint space under ultrasound visualization. Using a saline-filled syringe, the loss-of-resistance technique will be employed to confirm passage through the joint space and entry into the retroperitoneal space. Subsequently, a lateral fluoroscopic image will be obtained, and contrast medium will be injected to verify needle placement. If appropriate contrast dispersion is observed along the midline, the procedure will be considered successful, and the medication will be administered. If contrast distribution is inadequate (e.g. vascular spread, non-midline spread), the procedure will be discontinued under ultrasound guidance and resumed under fluoroscopic guidance.
Time frame
Post-procedure 1st hourSecondary outcomes
1
Visual Analogue Scale
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10-point scale where 1 indicates no pain and 10 represents the worst pain.
Time frame
Baseline, 1st hour, 1st week, 1st month2
Pain-free sitting duration
Pain-free sitting duration (minutes) will be recorded.
Time frame
Baseline, 1st hour, 1st week, 1st month3
The number of attempts
The number of attempts will be recorded.
Time frame
Post-procedure 1st hour4
Technical difficulty of injection
The technical difficulty of the injection will be assessed using a 10-item scale, where 1 indicates no difficulty and 10 represents the highest level of difficulty
Time frame
Post-procedure 1st hourSponsors and contacts
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Source ClinicalTrials.gov
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