Ultrasound-Guided Erector Spinae Plane Block in Major Spinal Surgery

NCT07101198 | Completed

• 1 other identifier: 2023-676
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of ultrasound-guided bilateral erector spinae plane block on intraoperative pain control and bleeding in patients undergoing major spinal surgery. Participants will be randomly assigned to two groups: one group will receive the Erector Spinae Plane block, while the other group will receive standard pain management. Primary outcomes include postoperative pain levels and intraoperative blood loss. This study seeks to determine whether the Erector Spinae Plane Block technique positively contributes to patient recovery and reduces bleeding complications.

Conditions

Perioperative Bleeding; Opioid Consumption; Erector Spinae Plane Block; Spinal Stabilization

Keywords

Spine Surgery; Regional Anesthesia; Blood Loss; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Intraoperative estimated blood loss

  Intraoperative estimated blood loss (milliliters) Total amount of blood lost during surgery will be measured in milliliters. \[Time Frame: During surgery\]

  During surgery

Secondary Outcomes (1)

• Total intraoperative remifentanil consumption

  During surgery

Study Arms (2)

Erector Spinae Plane Block Group

EXPERIMENTAL

Participants in this group received an ultrasound-guided Erector Spinae Plane Block preoperatively as part of multimodal analgesia.

Procedure: Ultrasound-guided erector spinae plane block

Control Group

NO INTERVENTION

Participants in this group did not receive a preoperative regional anesthesia block. Standard postoperative analgesic protocols were used.

Interventions

Ultrasound-guided erector spinae plane block PROCEDURE

Patients in this group will receive an ultrasound-guided erector spinae plane block 30 minutes before surgery. A total volume of bupivacaine will be injected bilaterally into the fascial plane between the erector spinae muscle and the transverse process. All patients will also receive standard postoperative analgesia.

Erector Spinae Plane Block Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older
• Scheduled for elective spinal stabilization surgery
• American Society of Anesthesiologists (ASA) physical status I-III
• Provided written informed consent

You may not qualify if:

• Anatomical barrier or infection at the Erector Spinae Plane Block site
• Known allergy to local anesthetics or opioids

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Etlik city hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Funda Atar, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

• Derya Özkan, prof

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group assignments. An anesthesiologist not involved in postoperative data collection will perform the Erector Spinae Plane Block.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to receive either ultrasound-guided Erector Spinae Plane Block or no block prior to lumbar spinal stabilization surgery.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 3, 2025
• Study Start: July 24, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 16, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)