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NCT Number: NCT06886568

Ultrasound Guided Ganglion Impar Block

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.

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Key information

Conditions

Coccydynia Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Ganglion impar blocks have long been used for coccydynia, either with a landmark-based technique or fluoroscopic guidance. With the growing use of ultrasound, ultrasound-guided ganglion impar block has become a viable alternative.

Despite its frequent use in clinical practice, ultrasound has limitations in visualizing structures behind the bone, while fluoroscopy remains the gold standard. Further research is needed to evaluate its feasibility, safety, and efficacy.

This study primarily aims to assess the feasibility and safety of ultrasound-guided ganglion impar block in coccydynia. Additionally, it will examine its short-term (1-month) efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Aggreeing to undergo the interventional procedure and participate in the study.

Exclusion criteria

  • 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

Treatment and study plan

Ultrasound-guided ganglion impar block

Procedure

The 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.

Primary outcomes

  1. Injection accuracy

    Time frame: Post-procedure 1st hour

    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.

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: Baseline, 1st hour, 1st week, 1st month

    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.

  2. Pain-free sitting duration

    Time frame: Baseline, 1st hour, 1st week, 1st month

    Pain-free sitting duration (minutes) will be recorded.

  3. The number of attempts

    Time frame: Post-procedure 1st hour

    The number of attempts will be recorded.

  4. Technical difficulty of injection

    Time frame: Post-procedure 1st hour

    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

  5. Complications

    Time frame: Baseline, 1st hour, 1st week, 1st month

    All complications following the injection will be recorded, including infections, bleeding, hematoma, allergic reactions, steroid-related complications, transient hypoesthesia, and weakness, among others.

Study contacts

Contact information is provided by the study sponsor or research team.

Duygu Karali-Bingul, MD

CONTACT

[email protected]

Tuba Tanyel Saraçoğlu, MD

CONTACT

[email protected]

00902129096000 ext. 30721

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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