Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia

NCT ID: NCT06858917

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-10-15

Brief Summary

Coccygodynia is a condition that causes pain in the tailbone (coccyx) area. While it can develop after trauma, such as a fall or fracture, in some cases, no clear cause is identified. Patients who do not experience relief from standard treatments like pain medications, physical therapy, and posture adjustments may be referred to specialized pain management clinics for further treatment options.

Several interventional procedures can help manage coccygodynia. These include impar ganglion block, radiofrequency ablation, caudal epidural steroid injections, sacral erector spinae plane (ESP) block, and coccygeal nerve blocks. These procedures are commonly performed in pain treatment centers and aim to reduce discomfort by targeting specific nerves responsible for transmitting pain signals.

Impar ganglion block is one of the most frequently used treatments for coccygodynia. It involves injecting a local anesthetic, with or without steroids, into a small nerve cluster in front of the sacrococcygeal joint. This procedure is performed under ultrasound and/or fluoroscopic (X-ray) guidance in a sterile operating room setting to ensure accuracy and safety. While the goal is to relieve pain, potential risks include temporary worsening of pain, bleeding, infection, or, in rare cases, rectal injury.

Another interventional option is the sacral erector spinae plane (ESP) block, a technique that delivers local anesthetic under the erector spinae muscles in the sacrum. This procedure, also performed under ultrasound guidance in a sterile environment, is used to block pain signals from the coccyx and surrounding areas. Like the impar ganglion block, it can be effective for pain relief, but possible side effects include temporary pain increase, bleeding, and infection at the injection site.

Both procedures are minimally invasive.

Detailed Description

Coccygodynia is defined as pain localized in the coccygeal region. While previous trauma and fractures may contribute to its development, in many cases, no identifiable etiology can be determined. Patients who continue to experience pain despite conservative treatment and physiotherapy are often referred to pain management outpatient clinics for interventional treatment options. Various interventional procedures are utilized in the management of coccygodynia, including impar ganglion block and radiofrequency applications, caudal epidural steroid injections, sacral erector spinae plane block, and coccygeal nerve blocks, all of which are commonly performed in pain treatment clinics. Impar ganglion block is administered under sterile conditions in the sacrococcygeal region within an operating room setting, utilizing ultrasound and/or fluoroscopic guidance. This procedure aims to alleviate pain; however, potential complications include increased pain, bleeding at the procedural site, rectal perforation, and infection. Sacral erector spinae plane block is another interventional approach performed under sterile conditions in the operating room using ultrasound guidance. Similar to the impar ganglion block, its primary objective is pain reduction, though it also carries risks such as increased pain, bleeding, and infection at the procedural site

Conditions

Coccygodynia; Coccydynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ganglion İmpar Block Group

Participants in this group will performed ganglion impar block

Group Type: ACTIVE_COMPARATOR

Ganglion Impar Block

Intervention Type: PROCEDURE

Block of the ganglion impar is performed by injecting a mixture of steroid and local anaesthetic in front of the sacrococcygeal joint. This procedure is performed in a sterile operating theatre under ultrasound and/or fluoroscopic (X-ray) guidance. Radiopaque agents are also used during the procedure to confirm the location.

Sacral Erector Spinae Plane Block

Participants in this group will performed sacral erector spinae plane block

Group Type: ACTIVE_COMPARATOR

Sacral Erector Spinae Plane Block

Intervention Type: PROCEDURE

The sacral erector spina plan block is performed with ultrasound guidance by injecting a high volume mixture of local anaesthetic and steroid into the fascia under the erector spina muscles in the sacral region.

Interventions

Ganglion Impar Block

Block of the ganglion impar is performed by injecting a mixture of steroid and local anaesthetic in front of the sacrococcygeal joint. This procedure is performed in a sterile operating theatre under ultrasound and/or fluoroscopic (X-ray) guidance. Radiopaque agents are also used during the procedure to confirm the location.

Intervention Type: PROCEDURE

Sacral Erector Spinae Plane Block

The sacral erector spina plan block is performed with ultrasound guidance by injecting a high volume mixture of local anaesthetic and steroid into the fascia under the erector spina muscles in the sacral region.

Intervention Type: PROCEDURE

Other Intervention Names

impar block; Sacral multifidus plane block

Eligibility Criteria

Inclusion Criteria

• Those who have had chronic coccygodynia for at least 3 months
• Being between the ages of 18-65
• Patients who do not respond to conservative treatments (analgesics, physical therapy modalities etc.) and are scheduled for interventional pain procedures

Exclusion Criteria

• Patients who have undergone surgery to the coccyx region
• Having undergone an interventional pain procedure in the lumbar, sacral and coccyx regions within the last year
• Patients with systemic infection, local infection at the application site, and coagulopathy
• Pregnant and breastfeeding patients
• Having endocrine or rheumatological disease that may affect the musculoskeletal system in the relevant region and lead to diagnostic complexity (such as spondyloarthropathy)
• Patients with musculoskeletal system pathology that may contribute to symptoms in the relevant region and affect the evaluation of treatment results (such as lumbar disc herniation, sacroiliitis, spinal stenosis)
• Those with lumbar, sacral or coccygeal vertebra fractures
• Those with a history of allergic reactions to the contents of the injectate to be administered during an interventional pain procedure (especially contrast agent and local anesthetic)
• Those with mental disorders that may affect the evaluation during the follow-up periods during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tuba Tanyel Saraçoğlu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuba Tanyel Saraçoğlu

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Tuba Tanyel Saraçoğlu, Medical Doctor

Role: CONTACT

tuba.saracoglu1@saglik.gov.tr

+0905396210136

Facility Contacts

Tuba Tanyel Saraçoğlu, Medical Doctor

Role: primary

tuba.saracoglu1@saglik.gov.tr

+0905396210136

Other Identifiers

22.05.2024.01

Identifier Type: -

Identifier Source: org_study_id