Clinical trial NCT06886568: Ultrasound Guided Ganglion Impar Block
Official title: Ultrasound Guided Ganglion Impar Block
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coccydynia
Chronic Pain
Keywords: Coccydynia
pain
ultrasound guided injection
ganglion impar
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Injection accuracy
timeFrame: Post-procedure 1st hour
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline, 1st hour, 1st week, 1st month
measure: Pain-free sitting duration
timeFrame: Baseline, 1st hour, 1st week, 1st month
measure: The number of attempts
timeFrame: Post-procedure 1st hour
measure: Technical difficulty of injection
timeFrame: Post-procedure 1st hour
measure: Complications
timeFrame: Baseline, 1st hour, 1st week, 1st month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Başakşehir
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Duygu Karali-Bingul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.