To hear about similar clinical trials, please enter your email below
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