Comparing two types of anesthesia for anal fistula surgery
Comparative Study Between Caudal and Perianal Block on Intraoperative Anal Sphincter Muscle Tone and Postoperative Analgesia During Anal Sphincter Sparing Procedures Under General Anesthesia
NA · Cairo University · NCT05557734
This study is testing which type of anesthesia works better for pain relief during anal fistula surgery in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05557734 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of caudal block analgesia versus perianal block analgesia in patients undergoing sphincter sparing surgery for complex anal fistulas. A total of 46 patients aged 18-60 will be randomly assigned to receive either type of block in conjunction with general anesthesia. The study aims to assess postoperative pain relief and the preservation of external anal sphincter tone. Patients will undergo routine preanesthetic evaluations and will be monitored throughout the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with complex anal fistulas who are classified as ASA I-III.
Not a fit: Patients with contraindications to regional anesthesia, such as known hypersensitivity to local anesthetics or certain cardiovascular conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management and better preservation of anal sphincter function for patients undergoing surgery for anal fistulas.
How similar studies have performed: While similar approaches have been explored, this specific comparison of caudal versus perianal block in the context of sphincter sparing procedures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-60 years old patients * ASA I-IIIpatients * Patients with complex anal fistula Exclusion Criteria: * known hypersensitivity to amide type local anesthetics * Patients with contraindications to caudal block or perianal block: use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure and severe aortic and / or mitral valve stenosis. * Patients who do not accept regional anesthesia * BMI (Body mass index) \> 35 kg/m2 * Anatomical abnormalities and previous surgeries involving the sacrum
Where this trial is running
Cairo
- Cairo university hospitals — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Osama M Assad, professor — Anesthesia department , cairo university
- Study coordinator: Abdelmoneim A Abdelmoneim, lecturer
- Email: abdelmoneim_adel@kasralainy.edu.eg
- Phone: 01004392046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Post Operative Pain, Motor Activity, caudal, perianal block, anal sphincter sparing procedures, postoperative pain