Impar VS Coccygeal Block in the Treatment of Coccidine

Not Applicable

Active, not recruiting

• Conditions: Coccyx Injury; Coccygeal Body Tumor
• Interventions: Device: Pericoccygeal nerve block; Procedure: Impar ganglion block

• Registration Number: NCT06242587
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.

Detailed Description

Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.

Study Timeline

• Study Start: 2023-11-02
• Study First Submitted: 2024-01-13
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-04-18
• Study Completion: 2024-05-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Coccygeal pain

Exclusion Criteria

• Malignite
• Infection
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Pericoccygeal block	Pericoccygeal nerve block	Patients undergoing pericoccygeal block
Group Impar ganglion block	Impar ganglion block	Patients undergoing impar ganglion block

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	Before treatment, week 4 and week 12	A Visual Analogue Scale (VAS) is the pain rating scales. Numbers 0-10 represent the severity of the patients' pain. No pain : 0, Most severe pain : 10

Secondary Outcome Measures

Name	Time	Method
PARIS coccidini scale	Before treatment, week 4 and week 12	Aims to measure functionality. There are options asking whether there is pain during movements such as sitting, standing, walking. the highest value is 10, the lowest value is 0

Trial Locations

Locations (1)

Gevher Rabia Genç Perdecioğlu; 🇹🇷 Ankara, Çankaya, Turkey