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Trial Title: Impar VS Coccygeal Block in the Treatment of Coccidine

NCT ID: NCT06242587

Condition: Coccyx Injury
Coccygeal Body Tumor

Conditions: Keywords:
Coccigodynia
Coccigeal pain treatment
Pericoccigeal nerve block
Impar ganglion block

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Pericoccygeal nerve block
Description: The coccygeal corneas are visualised with a linear probe under ultrasound guidance. The pericoccygeal nerves are located medial to the cornu and a combination of local anaesthetic and dexamethasone is injected.
Arm group label: Group Pericoccygeal block

Intervention type: Procedure
Intervention name: Impar ganglion block
Description: The sacrum is visualised with fluoroscopy. A needle is inserted through the sacrococcygeal junction. The optimal image is obtained by administering contrast material. A combination of local anaesthetic and dexamethasone is injected.
Arm group label: Group Impar ganglion block

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Coccygeal pain Exclusion Criteria: - Malignite - Infection - Pregnancy

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gevher Rabia Genç Perdecioğlu

Address:
City: Ankara
Zip: 06010
Country: Turkey

Start date: November 2, 2023

Completion date: May 19, 2024

Lead sponsor:
Agency: Diskapi Teaching and Research Hospital
Agency class: Other

Source: Diskapi Teaching and Research Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06242587

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