Ultrasound-Guided Erector Spinae Plane Block in Major Spinal Surgery

NCT ID: NCT07101198

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-24

Study Completion Date

2025-09-16

Brief Summary

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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.

Detailed Description

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This randomized controlled trial investigates the effectiveness of ultrasound-guided bilateral Erector Spinae Plane Block on intraoperative opioid consumption and bleeding in patients undergoing spinal surgery. Eligible adult patients will be enrolled after obtaining informed consent.

Participants will be randomly assigned to two groups: the intervention group will receive bilateral Erector Spinae Plane Block under ultrasound guidance before surgery, while the control group will receive standard pain management without the block. The Erector Spinae Plane Block will be performed using a standard dose of bupivacaine.

The primary outcome measure is the amount of intraoperative bleeding. Secondary outcomes include opioid consumption and incidence of complications.

This study aims to provide evidence on the efficacy of the Erector Spinae Plane Block technique in improving postoperative recovery and reducing bleeding complications in major spinal surgeries.

Conditions

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Perioperative Bleeding Opioid Consumption Erector Spinae Plane Block Spinal Stabilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Erector Spinae Plane Block Group

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

Group Type EXPERIMENTAL

Ultrasound-guided erector spinae plane block

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound-guided erector spinae plane block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

Anatomical barrier or infection at the Erector Spinae Plane Block site

Known allergy to local anesthetics or opioids

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Funda Atar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Funda Atar, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Derya Özkan, prof

Role: STUDY_DIRECTOR

Ankara Etlik City Hospital

Locations

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Etlik city hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-676

Identifier Type: -

Identifier Source: org_study_id

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