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Recruiting NCT06969274

NCT06969274 Ultrasound-guided Sacral Erector Spinae Plane Block as a Sole Anesthetic Technique Versus Saddle Block in Hemorrhoidectomy

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Clinical Trial Summary
NCT ID NCT06969274
Status Recruiting
Phase
Sponsor Ain Shams University
Condition Hemorrhoids
Study Type INTERVENTIONAL
Enrollment 50 participants
Start Date 2025-05-29
Primary Completion 2025-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Ultrasound guided sacral erector spinae plane block (SESPB)Saddle block.

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 50 participants in total. It began in 2025-05-29 with a primary completion date of 2025-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Study interventions: The patients will be randomized into two equal groups, Group A and Group B. Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB) Group B: Patients will receive Saddle block. The surgical procedure will be performed by an experienced surgeon. The outcome: The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 0, 2, 4, 6, 12, and 24 hours after the procedure. The secondary outcomes will include the cumulative doses of tramadol (50 mg intramuscular) to be repeated every 8 hours in case NRS score is more than four, the number of patients requiring rescue medication in the postoperative period.

Eligibility 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.

Contact & Investigator

Central Contact

Riham F Nady, MD

✉ rihamfathygalal@gmail.com

📞 +21022739211

Frequently Asked Questions

Who can join the NCT06969274 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hemorrhoids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06969274 currently recruiting?

Yes, NCT06969274 is actively recruiting participants. Contact the research team at rihamfathygalal@gmail.com for enrollment information.

Where is the NCT06969274 trial being conducted?

This trial is being conducted at Cairo, Egypt.

Who is sponsoring the NCT06969274 clinical trial?

NCT06969274 is sponsored by Ain Shams University. The trial plans to enroll 50 participants.

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