NCT06459739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

June 5, 2024

Last Update Submit

February 25, 2025

Conditions

Pain, Acute Post-OperativePilonidal SinusHemorrhoidsAnesthesia

Keywords

Sacral ESPBPostoperative painHemorrhoidectomyPilonidal sinus surgeryAnalgesia

Outcome Measures

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.

    0.5,2,8,24 hours

Secondary Outcomes (1)

  • Opioid consumption

    0.5,2,8,24 hours

Study Arms (2)

sacralESPB

EXPERIMENTAL

Sacral ESPB group

Procedure: sacral ESPB

Control

NO INTERVENTION

Interventions

sacral ESPBPROCEDURE

sacral ESPB

sacralESPB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yildirim university

Erzincan, 24100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePilonidal SinusHemorrhoidsAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsCystsNeoplasmsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 14, 2024

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

TU(1)