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RecruitingNCT07534488Updated Jul 27, 2026

Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery

An interventional study of Sacral Erector Spinae Plane Block and Standard Postoperative Analgesia in Sacral Erector Spinae Plane Block and Pilonidal Sinus, sponsored by Medipol University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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

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Conditions studied

  • Sacral Erector Spinae Plane Block
  • Pilonidal Sinus

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03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Sacral ESPB Group

    Procedure: Sacral Erector Spinae Plane Block

  • Active comparator
    Control Group

    Drug: Standard Postoperative Analgesia

Interventions

  • ProcedureSacral 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.

  • DrugStandard 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

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What researchers measure

Primary outcomes

  1. 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

  1. 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.

  2. 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.

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07534488
Lead sponsor
Medipol University
Responsible party
Burak Omur (Assistant Professor, Medipol University) — Principal investigator
First posted
Apr 16, 2026
Start date
Apr 20, 2026
Primary completion
Aug 1, 2026 (estimated)
Completion
Sep 15, 2026 (estimated)
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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