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Assessing the effect of drug treatment with a needle from the coccyx in patients with chronic anal fissure

The Effect of Caudal Epidural Injection on Healing in the Treatment of Chronic Anal Fissure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000751673
Enrollment
30
Registered
2023-07-11
Start date
2023-07-03
Completion date
Unknown
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this study was to test the hypothesis that caudal epidural injection provides a more effective improvement to medical treatment in patients with chronic anal fissure. In addition, the secondary aim of our study was to show that caudal epidural injection provides a significant improvement in the quality of life of patients with chronic anal fissures because they have less constipation.

Interventions

A Hundred twenty consecutive patients with the diagnosis of chronic anal fissure were enrolled this randomized, controlled study. Caudal epidural injection group (Group K, n=60) was treated with 5cc bupivacain + 5cc isotonic from a caudal epidural for a total of 3 sessions at the beginning, 1 week and 2 weeks later; The patients who were taken to the surgery room were monitored using electrocardiography, arterial pressure(noninvasive) and pulse oximetry, and baseline values were recorded. 10 ml

A Hundred twenty consecutive patients with the diagnosis of chronic anal fissure were enrolled this randomized, controlled study. Caudal epidural injection group (Group K, n=60) was treated with 5cc bupivacain + 5cc isotonic from a caudal epidural for a total of 3 sessions at the beginning, 1 week and 2 weeks later; The patients who were taken to the surgery room were monitored using electrocardiography, arterial pressure(noninvasive) and pulse oximetry, and baseline values were recorded. 10 ml for each patient. 0.25% Bupivacaine (Marcain, OSEL) was prepared using a syringe. A pillow was placed in the pelvic region of patients in the prone position. After the area was cleaned and covered, the sacral hiatus was determined by palpation by the anesthesiologist and a 22 G 9 cm needle was pushed forward until bone was touched at a 45° angle to the skin. Then, the angle of the needle, which was withdrawn to the skin, was decreased from 20° to 5°, and it was pushed forward 5-6 cm into the epidural distance by passing through the sacrococcygeal ligament. After observing that the blood and cerebrospinal fluid did not result in negative aspiration, the prepared bupivacaine was injected.The approximate duration of each caudal epidural injection session was 15 minutes. The diagnosis of chronic anal fissure and the evaluation of the anal fissure during the caudal epidural injection(CEI) procedure were performed by an expert colorectal surgeon.

Sponsors

ERHAN GÖKÇEK
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients were included in the study if they were older than 18 years or older with chronic anal fissure for at least 6 months.

Exclusion criteria

Exclusion criteria were pregnancy, diabetes mellitus, neurological diseases, spinal cord lesions, and use of cardiac pacemaker or an implantable cardiac defibrillator. Age <18 or >70 years patients

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026