NCT06670313

Brief Summary

Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

October 25, 2024

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • primary outcome

    1\. Systolic arterial pressure,

    one day

Secondary Outcomes (1)

  • Sevondary outcome

    one day

Study Arms (2)

Preop Erector spinae plane block

ACTIVE COMPARATOR

Patients who underwent erector spinae block before surgery

Other: postop Erector spinae plane block

postop Erector spinae plane block

ACTIVE COMPARATOR

Patients who underwent erector spinae block without waking the patient at the end of surgery

Other: postop Erector spinae plane block

Interventions

Postoperative ESP block was performed as the control group

Preop Erector spinae plane blockpostop Erector spinae plane block

Eligibility Criteria

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

You may qualify if:

  • According to the physical classification of the American Society of Anesthesiologists (ASA), ASA I-II group,
  • between the ages of 18-65,

You may not qualify if:

  • Patients who do not want to participate in the study;
  • BMI \>30,
  • Patients with contraindications for ESP block,
  • Uncooperative patients,
  • Those with renal failure,
  • Those with hepatic failure and
  • ASA III-IV-V group patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind: Participants were blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2024

First Posted

November 1, 2024

Study Start

November 11, 2024

Primary Completion

June 12, 2025

Study Completion

June 25, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations