Ultrasound-guided sacral erector spinae plane block versus saddle block for anesthesia during hemorrhoidectomy
Official title: Ultrasound-guided Sacral Erector Spinae Plane Block as a Sole Anesthetic Technique Versus Saddle Block in Hemorrhoidectomy
Run by Ain Shams University · NCT06969274 · Data updated 2026-11-12
This will test whether an ultrasound-guided sacral erector spinae plane block works as well as a saddle block for adults having hemorrhoidectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | May 29, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT06969274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ASA I–II adults aged 18–65 years scheduled for perianal surgery (hemorrhoidectomy) without coagulopathy, major liver or kidney impairment, spinal malformation, drug hypersensitivity, or prior hemorrhoidectomy.
✕Probably not a fit
Patients with coagulopathy, spinal malformations, significant hepatic or renal impairment, known drug hypersensitivity, prior hemorrhoidectomy, or those outside the 18–65 age range are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for hemorrhoidectomy are randomly assigned to receive either an ultrasound-guided sacral erector spinae plane block (SESPB) or a saddle block as the sole anesthetic. Randomization is computer-generated with allocation via sealed opaque envelopes and the anesthesiologist performing the block is given the assignment. Pain intensity is measured using the Numerical Rating Scale (NRS) at 0, 2, 4, 6, 12, and 24 hours after surgery, and postoperative tramadol use and need for rescue medication are recorded. Standard perioperative monitoring and an institutional analgesia protocol (tramadol 50 mg IM every 8 hours if NRS > 4) are applied to all participants.
Why it matters
Potential benefit: If successful, the SESPB approach could improve postoperative pain control and reduce opioid requirements after hemorrhoidectomy.
How similar studies have gone: Saddle block is an established anesthetic for perianal surgery, while sacral erector spinae plane blocks are a newer regional technique with limited but growing evidence for postoperative analgesia, making direct comparisons relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with American Society of anesthesiologists' physical status (ASA) I to II. 2. Aged 18 to 65 years. 3. Both sexes. 4. Patients scheduled for perianal surgeries (hemorrhoidectomy). Exclusion Criteria: * 1- Patients with spinal malformation. 2-Patients with liver impairment. 3- Patients with renal impairment. 4-Patients younger than 18 years or older than 65 years. 5- Patients with hypersensitivity to one of the used drugs. 6- Coagulopathy disorders. 7- Patients who underwent hemorrhoidectomy before.
Where it's running
-
Ain Shams University Hospitals
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Riham F Nady, MD
- Email: rihamfathygalal@gmail.com
- Phone: +21022739211
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.