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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Coccydynia
• Intervention / Treatment: Procedure: Ultrasound-guided ganglion impar block

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuba Tanyel Saraçoğlu, MD; Phone Number: 30721 00902129096000; Email: tuba.saracoglu1@saglik.gov.tr
• Study Contact Backup: Name: Duygu Karali-Bingül, MD; Email: d_karali@yahoo.com

Study Locations

• Turkey
  • Başakşehir
    • Istanbul, Başakşehir, Turkey
      • Basaksehir Cam and Sakura City Hospital
      • Contact: Duygu Karali-Bingül, MD; Email: d_karali@yahoo.com
      • Contact: Tuba Tanyel Saraçoğlu, MD; Phone Number: +0905396210136; Email: tuba.saracoglu1@saglik.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Injection Group; Ganglion impar block will be applied under ultrasound guidance

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-procedure 1st hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1st hour, 1st week, 1st month
Pain-free sitting duration	Pain-free sitting duration (minutes) will be recorded.	Baseline, 1st hour, 1st week, 1st month
The number of attempts	The number of attempts will be recorded.	Post-procedure 1st hour
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	Post-procedure 1st hour
Complications	All complications following the injection will be recorded, including infections, bleeding, hematoma, allergic reactions, steroid-related complications, transient hypoesthesia, and weakness, among others.	Baseline, 1st hour, 1st week, 1st month

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Investigators: Principal Investigator: Duygu Karali-Bingul, MD, Başakşehir Çam & Sakura City Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: pain; Coccydynia; ultrasound guided injection; ganglion impar
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms; Connective Tissue Diseases; Cysts; Mucinoses; Chronic Pain; Ganglion Cysts
• Other Study ID Numbers: 2022.03.98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No