Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery

April 9, 2026 updated by: Burak Omur, Medipol University

Evaluation of the Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block in Postoperative Analgesia Management in Patients Undergoing Pilonidal Sinus Surgery

This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Severe pain after pilonidal sinus surgery is a significant problem that reduces patient comfort. In this randomized, prospective study, patients will be divided into two groups (Sacral ESPB group and control group) using a computer randomization method before the surgery. In the Sacral ESPB group, the block will be performed under ultrasound guidance using a 20 ml local anesthetic volume immediately after the surgical procedure and before extubation. The study will compare postoperative rescue analgesic requirement, opioid consumption, pain scores (NRS), and the incidence of side effects and complications

Study Type

Interventional

Enrollment (Estimated)

60

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

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:

  • Patients scheduled for elective pilonidal sinus surgery.
  • ASA physical status I and II

Exclusion Criteria:

  • Allergy or sensitivity to local anesthetics or opioid drugs.
  • Infection at the block site.
  • Alcohol or drug addiction.
  • Use of anticoagulant agents.
  • Patient refusal.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Drug: Standard Postoperative Analgesia
No block will be applied to this group. Both groups will receive intravenous 400 mg ibuprofen and 100 mg tramadol 20 minutes before the end of the surgery, and routine 1000 mg paracetamol every 8 hours postoperatively
Experimental: Sacral ESPB Group
Procedure: Sacral Erector Spinae Plane Block
Immediately after the surgical procedure and before extubation, ultrasound-guided (Vivid Q) Sacral ESPB will be applied to the patient in the prone position using a total volume of 20 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative rescue analgesic (opioid) consumption.
Time Frame: At 24 hours postoperatively (Cumulative total over the 24-hour period)
Total amount of intravenous tramadol administered as a rescue analgesic will be recorded
At 24 hours postoperatively (Cumulative total over the 24-hour period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)
Time Frame: At 1, 3, 6, 12, 18, and 24 hours postoperatively.
Pain scores will be evaluated at rest and during movement using a 0-10 NRS (0= no pain, 10= most severe pain).
At 1, 3, 6, 12, 18, and 24 hours postoperatively.
Incidence of opioid-related side effects and block-related complications.
Time Frame: During the 24-hour postoperative period.
Occurrence of side effects such as nausea, vomiting, itching, allergic reactions, and complications like hematoma will be recorded.
During the 24-hour postoperative period.

Collaborators and Investigators

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

Sponsor

Medipol University

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 (Estimated)

April 20, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medipol 374, 20.03.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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