Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-01
2025-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia
NCT06858917
Efficacy of Combining Caudal Epidural Steroid With Ganglion Impar Block in Chronic Coccydynia
NCT07200765
Impar VS Coccygeal Block in the Treatment of Coccidine
NCT06242587
Stellate Ganglion Block in Complex Regional Pain Syndrome
NCT07129811
TARGETING DUAL PATHWAYS IN REFRACTORY COCCYDYNIA
NCT07060313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Injection Group
Ganglion impar block will be applied under ultrasound guidance
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tuba Tanyel Saraçoğlu
MD, Head of Algology Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Duygu Karali-Bingul, MD
Role: PRINCIPAL_INVESTIGATOR
Başakşehir Çam & Sakura City Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022.03.98
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.