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CompletedNCT06459739Updated Feb 27, 2025

Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery

An interventional study of sacral ESPB in Pain, Acute Post-Operative, Pilonidal Sinus and Hemorrhoids, sponsored by Erzincan Binali Yildirim Universitesi. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Erzincan Binali Yildirim Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Read the detailed description

Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

02

Conditions studied

  • Pain, Acute Post-Operative
  • Pilonidal Sinus
  • Hemorrhoids
  • Anesthesia

Keywords

  • Sacral ESPB
  • Postoperative pain
  • Hemorrhoidectomy
  • Pilonidal sinus surgery
  • Analgesia
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 70 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Erzincan Binali Yildirim Universitesi is the lead sponsor of 23 studies on the registry; 10 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 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

  • (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery

Exclusion criteria

Exclusion Criteria:

  • patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were for it, and patients who had previously undergone the same surgery
Terms in these criteria, in plain language(2)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    sacralESPB

    Sacral ESPB group

    Procedure: sacral ESPB

  • No intervention
    Control

Interventions

  • Proceduresacral ESPB

    sacral ESPB

06

What researchers measure

Primary outcomes

  1. Postoperative pain

    Numeric rating scale evaluation after surgery. Use 0 to 10 points with 0 no pain 5 moderate pain and 10 severe pain.

    Time frame: 0.5,2,8,24 hours

Secondary outcomes

  1. Opioid consumption

    Admission of tramadol as a rescue analgesia

    Time frame: 0.5,2,8,24 hours

07

Study locations

1 site
  • Erzincan Binali Yildirim university
    Erzincan, 24100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06459739
Lead sponsor
Erzincan Binali Yildirim Universitesi
Responsible party
Alparslan Koc (Assoc. Prof., Erzincan Binali Yildirim Universitesi) — Principal investigator
First posted
Jun 14, 2024
Start date
Sep 1, 2023
Primary completion
Mar 1, 2024
Completion
Apr 1, 2024
Last update
Feb 27, 2025

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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