Comparing 5-minute versus 8-minute sitting after saddle spinal anesthesia for faster discharge after perianal surgery
Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial
NA · Cairo University · NCT07466121
This trial will test whether sitting for 5 minutes versus 8 minutes after saddle spinal anesthesia helps adults having minor perianal surgery recover and be ready to go home sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07466121 on ClinicalTrials.gov |
What this trial studies
Adults aged 21–65 (ASA I–III) undergoing minor perianal surgery receive spinal saddle anesthesia at L4–5 using 7.5 mg of 0.5% hyperbaric bupivacaine, then are randomized to remain seated for either 5 or 8 minutes to compare anesthetic spread and recovery. Hemodynamic data (heart rate and blood pressure) are recorded at baseline and every 2 minutes until the end of surgery. Postoperative pain is measured with a numeric rating scale in the PACU and before discharge, with IV ketorolac and titrated nalbuphine provided for pain control and ondansetron for nausea/vomiting. The primary focus is readiness for discharge and quality of recovery (QoR-15) following the two sitting durations.
Who should consider this trial
Good fit: Adults 21–65 years old with ASA physical status I–III scheduled for perianal surgery who are eligible for neuraxial anesthesia are ideal candidates.
Not a fit: Patients with contraindications to neuraxial anesthesia, significant cardiac disease (e.g., EF <40%, unstable arrhythmias), pregnant or lactating women, or those requiring general anesthesia are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, this could shorten recovery time and increase same-day discharges after minor perianal procedures.
How similar studies have performed: Prior work shows saddle block reliably anesthetizes the perineum and can speed recovery compared with general anesthesia, but comparisons of exact sitting durations are limited and have shown mixed or inconclusive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (21-65 years), ASA I-III undergoing perianal surgery. Exclusion Criteria: * Severe cardiac morbidities (impaired contractility with ejection fraction \< 40%, heart block, arrhythmias, tight valvular lesions) * Contraindication to neuraxial anesthesia such as coagulopathy and local infection * Pregnant or lactating women, * Allergy of any of the study drugs
Where this trial is running
Cairo, Cairo Governorate
- Cairo University — Cairo, Cairo Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Maha Mostafa
- Email: maha.mostafa@cu.edu.eg
- Phone: +201000365115
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: Saddle Block Anesthesia, Readiness of Discharge, Quality of Recovery