Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery
Evaluation of the Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block in Postoperative Analgesia Management in Patients Undergoing Pilonidal Sinus Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2026
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedStudy Start
First participant enrolled
April 20, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
Study Completion
Last participant's last visit for all outcomes
June 15, 2026
April 16, 2026
April 1, 2026
1 month
April 9, 2026
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total postoperative rescue analgesic (opioid) consumption.
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 Outcomes (2)
Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)
At 1, 3, 6, 12, 18, and 24 hours postoperatively.
Incidence of opioid-related side effects and block-related complications.
During the 24-hour postoperative period.
Study Arms (2)
Sacral ESPB Group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- Patients scheduled for elective pilonidal sinus surgery.
- ASA physical status I and II
You may not qualify if:
- Allergy or sensitivity to local anesthetics or opioid drugs.
- Infection at the block site.
- Alcohol or drug addiction.
- Use of anticoagulant agents.
- Patient refusal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single Blind (Outcomes Assessor). Postoperative patient evaluation will be performed by another anesthesiologist who was not involved in the procedure.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 9, 2026
First Posted
April 16, 2026
Study Start (Estimated)
April 20, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 15, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share