Impar VS Coccygeal Block in the Treatment of Coccidine

Comparison of Coccygeal Block and Impar Block for the Treatment of Coccydynia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coccyx Injury; Coccygeal Body Tumor
• Intervention / Treatment: Device: Pericoccygeal nerve block; Procedure: Impar ganglion block

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06010
      • Gevher Rabia Genç Perdecioğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Coccygeal pain

Exclusion Criteria:

• Malignite
• Infection
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Pericoccygeal block; Patients undergoing pericoccygeal block	Device: Pericoccygeal nerve block; 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.
Active Comparator: Group Impar ganglion block; Patients undergoing impar ganglion block	Procedure: Impar ganglion block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	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	Before treatment, week 4 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PARIS coccidini scale	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	Before treatment, week 4 and week 12

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): April 18, 2024
• Study Completion (Estimated): May 19, 2024

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Coccigodynia; Coccigeal pain treatment; Pericoccigeal nerve block; Impar ganglion block
• Other Study ID Numbers: impar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No