Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery

Medipol University60 enrolled

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sacral Erector Spinae Plane Block Pilonidal Sinus

Interventions

Sacral Erector Spinae Plane BlockPROCEDURE

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.

Standard Postoperative AnalgesiaDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Total postoperative rescue analgesic (opioid) consumption.

Total amount of intravenous tramadol administered as a rescue analgesic will be recorded

Time frame: At 24 hours postoperatively (Cumulative total over the 24-hour period)

Secondary Outcomes

Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)

Pain scores will be evaluated at rest and during movement using a 0-10 NRS (0= no pain, 10= most severe pain).

Time frame: At 1, 3, 6, 12, 18, and 24 hours postoperatively.

Incidence of opioid-related side effects and block-related complications.

Occurrence of side effects such as nausea, vomiting, itching, allergic reactions, and complications like hematoma will be recorded.

Time frame: During the 24-hour postoperative period.

Data from ClinicalTrials.gov

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