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

NCT06969274 | Recruiting

• 1 other identifier: FAMSU R83/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.

  The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.

  Twenty Four hours after the procedure

Study Arms (2)

SESPB

EXPERIMENTAL

Procedure: Ultrasound guided sacral erector spinae plane block (SESPB)

Saddle

EXPERIMENTAL

Procedure: Saddle block.

Interventions

Ultrasound guided sacral erector spinae plane block (SESPB) PROCEDURE

Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)

SESPB

Saddle block. PROCEDURE

Patients will receive a Saddle block.

Saddle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American Society of anesthesiologists' physical status (ASA) I to II.
• Aged 18 to 65 years.
• Both sexes.
• Patients scheduled for perianal surgeries (hemorrhoidectomy).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Riham F Nady, MD

CONTACT

+21022739211; rihamfathygalal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, intensive care and pain medicine

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 13, 2025
• Study Start: May 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)