Effect of Sacral Erector Spinae Plane Block on Hemorrhoid... | NCT06459739

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

NCT06459739

Sponsor

Erzincan Binali Yildirim Universitesi

Status

Completed

Last Update Posted

Feb 27, 2025Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Pain, Acute Post-Operative
Pilonidal Sinus
Hemorrhoids
Anesthesia

Interventions

sacral ESPB

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Mar 1, 2024Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Jun 5, 2024

First Submission Date that Met QC Criteria

Jun 10, 2024

First Posted Date

Jun 14, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2025

Last Update Posted Date

Feb 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alparslan Koc, Assoc. Prof., Erzincan Binali Yildirim UniversitesiPrincipal Investigator

Lead Sponsor

Erzincan Binali Yildirim UniversitesiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sacralESPB	Experimental	Sacral ESPB group	Procedure: sacral ESPB
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sacral ESPB	Procedure	sacral ESPB	sacralESPB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	Numeric rating scale evaluation after surgery. Use 0 to 10 points with 0 no pain 5 moderate pain and 10 severe pain.	0.5,2,8,24 hours

Secondary Outcomes

Measure	Description	Time Frame
Opioid consumption	Admission of tramadol as a rescue analgesia	0.5,2,8,24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery

Exclusion Criteria:

patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were contraindicated for it, and patients who had previously undergone the same surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erzincan Binali Yildirim university		Erzincan		24100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D010864	Pilonidal Sinus
D006484	Hemorrhoids
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided