Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery

February 25, 2025 updated by: Alparslan Koc, Erzincan Binali Yildirim Universitesi
Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzincan, Turkey, 24100
        • Erzincan Binali Yildirim university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery

Exclusion Criteria:

  • patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were contraindicated for it, and patients who had previously undergone the same surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: sacralESPB
Sacral ESPB group
Procedure: sacral ESPB
sacral ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 0.5,2,8,24 hours
Numeric rating scale evaluation after surgery. Use 0 to 10 points with 0 no pain 5 moderate pain and 10 severe pain.
0.5,2,8,24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 0.5,2,8,24 hours
Admission of tramadol as a rescue analgesia
0.5,2,8,24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan Binali Yildirim Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SacralESPB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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