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Efficacy of Interventional Methods Used in the Treatment of Coccydynia

NCT06653179 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-10-23

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of sacral erector spinae plane block and caudal epidural injection in patients with coccydynia resistant to conservative treatments. Ultrasound guidance will be used for sacral erector spinae plane block, while fluoroscopic guidance will be applied for caudal epidural injection. The effectiveness of these treatments will be assessed through face-to-face questionnaires, the Numerical Rating Scale and the Paris Functional Coccydynia Scale at first, fourth and twelfth-week follow-ups.

Conditions

  • Coccydynia
  • Erector Spinae Plane Block
  • Caudal Block

Interventions

PROCEDURE

Sacral Erector Spinae Plane Block

The patient is placed in the prone positionon a procedure table. The sacral region is exposed, and the area is prepped with antiseptic solution under sterile conditions. The ultrasound high-frequency linear transducer is placed transversely over the sacrum. The sacral cornua are typically seen as bony structures adjacent to the sacral hiatus, appearing as two hyperechoic structures. Rotate the ultrasound probe to a sagittal position over the sacrum to align with the fourth and fifth sacral vertebrae. Under continuous ultrasound guidance, block needle is inserted in-plane with the ultrasound probe. Direct the needle through the soft tissue towards the plane between the erector spinae muscle and the sacrum. After confirming needle placement, the injectate mixture of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration) is administered. A total volume of 10 mL is injected, and real-time ultrasound is used to observe the spread of the injectate within the target tissue plane.

PROCEDURE

Caudal Epidural Injection

The patient is positioned in the prone position on the procedure table, and the sacral region is exposed and prepped with antiseptic solution under sterile conditions. The fluoroscope is positioned laterally to visualize the sacral hiatus. Under fluoroscopic guidance, the block needle is inserted through the skin and advanced toward the sacral hiatus. Continuous fluoroscopy is used to ensure correct needle placement, typically visualized at the level of the sacral canal. After confirming the appropriate position with contrast media, the injectate consisting of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration) is slowly administered, with a total volume of 10 mL. During injection, careful monitoring of the needle position is performed to avoid intravascular injection. After the procedure, patients are monitored for potential complications such as hypotension and allergic reactions.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-08-15
Completion
2025-11-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06653179 on ClinicalTrials.gov