Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06969274

Ultrasound-Guided Sacral Erector Spinae Plane Block Versus Saddle Block for Anesthesia in Hemorrhoidectomy Surgery

Led by Ain Shams University · Updated on 2025-12-02

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two anesthetic techniques for patients undergoing hemorrhoidectomy surgery: an Ultrasound guided sacral erector spinae plane block (SESPB) and a Saddle block. The study includes adult patients aged 18 to 65 years with certain physical health statuses, scheduled for perianal surgery. Researchers want to evaluate pain intensity and the need for additional pain medication after the procedure. Participants will be randomly assigned to one of two groups. Group A will receive the SESPB using ultrasound guidance to inject local anesthetics near the sacral area, while Group B will receive a Saddle block administered via spinal anesthesia. Both procedures are performed by an anesthesiology consultant, and the surgical operation is done by an experienced surgeon. Postoperative medications including paracetamol and diclofenac are given regularly, with tramadol available as rescue analgesia if pain scores exceed specified levels. During the study, pain levels will be measured using the Numerical Rating Scale (NRS) at multiple time points up to 24 hours after surgery. Researchers will also track the total tramadol doses needed and how many patients require extra pain medication. Vital signs and standard monitoring occur before and during the operation. Participants are followed closely during the postoperative period with scheduled pain assessments and medication administration to ensure accurate data collection and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with American Society of Anesthesiologists physical status I to II
  • Aged between 18 and 65 years
  • Both sexes
  • Scheduled for perianal surgery (hemorrhoidectomy)
Not Eligible

You will not qualify if you...

  • Patients with spinal malformations
  • Patients with liver impairment
  • Patients with renal impairment
  • Patients younger than 18 years or older than 65 years
  • Patients with hypersensitivity to any of the used drugs
  • Patients with coagulopathy disorders
  • Patients who have undergone hemorrhoidectomy before

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive either an ultrasound-guided sacral erector spinae plane block or a saddle block anesthesia prior to hemorrhoidectomy surgery.

1 visit (in-person)

Post-operative Follow-up

Duration - 24 hours after surgery

Participants are monitored for pain intensity and receive postoperative pain management for 24 hours after the procedure.

Pain assessments at 0, 2, 4, 6, 12, and 24 hours post-surgery

Trial Site Locations

Total: 1 location

1

Ain Shams University Hospitals

Cairo, Egypt

Actively Recruiting

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Research Team

R

Riham F Nady, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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