Ultrasound Guided Ganglion Impar Block

NCT06886568 | Not Yet Recruiting

• 1 other identifier: 2022.03.98
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccydynia; Chronic Pain

Keywords

Coccydynia; pain; ultrasound guided injection; ganglion impar

Outcome Measures

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.

  Post-procedure 1st hour

Secondary Outcomes (5)

• Visual Analogue Scale

  Baseline, 1st hour, 1st week, 1st month

• Pain-free sitting duration

  Baseline, 1st hour, 1st week, 1st month

• The number of attempts

  Post-procedure 1st hour

• Technical difficulty of injection

  Post-procedure 1st hour

• Complications

  Baseline, 1st hour, 1st week, 1st month

Study Arms (1)

Injection Group

EXPERIMENTAL

Ganglion impar block will be applied under ultrasound guidance

Procedure: Ultrasound-guided ganglion impar block

Interventions

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.

Injection Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duygu Karali-Bingul, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Tanyel Saraçoğlu, MD

CONTACT

00902129096000; tuba.saracoglu1@saglik.gov.tr

Duygu Karali-Bingul, MD

CONTACT

d_karali@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of Algology Department

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)