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Recruiting NCT07534488

Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery

No phase Interventional Sacral Erector Spinae Plane Block Pilonidal Sinus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacral Erector Spinae Plane Block, Standard Postoperative Analgesia.
Who it may be relevant to
Registry conditions: Sacral Erector Spinae Plane Block, Pilonidal Sinus. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Interventions

  • 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.
  • 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

Primary outcome measures

  • Total postoperative rescue analgesic (opioid) consumption. [Time frame: At 24 hours postoperatively (Cumulative total over the 24-hour period)]
Secondary outcome measures (2)
  • Postoperative pain scores evaluated by the Numeric Rating Scale (NRS) [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medipol University — Istanbul

Identifiers

NCT: NCT07534488 · Medipol 374, 20.03.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗