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Not yet recruiting NCT06886568

Ultrasound Guided Ganglion Impar Block

No phase Interventional Coccydynia Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided ganglion impar block.
Who it may be relevant to
Registry conditions: Coccydynia, Chronic Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Procedure Ultrasound-guided ganglion impar block
    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 obt

Primary outcome measures

  • Injection accuracy [Time frame: Post-procedure 1st hour]
Secondary outcome measures (5)
  • Visual Analogue Scale [Time frame: Baseline, 1st hour, 1st week, 1st month]
  • Pain-free sitting duration [Time frame: Baseline, 1st hour, 1st week, 1st month]
  • The number of attempts [Time frame: Post-procedure 1st hour]
  • Technical difficulty of injection [Time frame: Post-procedure 1st hour]
  • Complications [Time frame: Baseline, 1st hour, 1st week, 1st month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Başakşehir Çam and Sakura City Hospital — Istanbul

Publications

  • Li SQ, Jiang L, Cui LG, Jia DL. Clinical efficacy of ultrasound-guided pulsed radiofrequency combined with ganglion impar block for treatment of perineal pain. World J Clin Cases. 2021 Mar 26;9(9):2153-2159. doi: 10.12998/wjcc.v9.i9.2153. PMID 33850934
  • Ghai A, Jangra P, Wadhera S, Kad N, Karwasra RK, Sahu A, Jaiswal R. A prospective study to evaluate the efficacy of ultrasound-guided ganglion impar block in patients with chronic perineal pain. Saudi J Anaesth. 2019 Apr-Jun;13(2):126-130. doi: 10.4103/sja.SJA_667_18. PMID 31007658
  • Lin CS, Cheng JK, Hsu YW, Chen CC, Lao HC, Huang CJ, Cheng PH, Narouze S. Ultrasound-guided ganglion impar block: a technical report. Pain Med. 2010 Mar;11(3):390-4. doi: 10.1111/j.1526-4637.2010.00797.x. PMID 20447308

Identifiers

NCT: NCT06886568 · 2022.03.98

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗