Erector Spina Plane Block for Multilevel Major Spinal Surgery

NCT ID: NCT05983393

Last Updated: 2023-10-10

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-08-07

Brief Summary

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Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

Detailed Description

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Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.

Conditions

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Pain Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control group

No block was performed

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Erector spinae plane block was not applied.

Erector spinae plane block

Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

Erector spinae plane block was performed

Interventions

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Erector spinae plane block

Erector spinae plane block was performed

Intervention Type PROCEDURE

Control

Erector spinae plane block was not applied.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-III patients
* Agreed to participate in the study

Exclusion Criteria

* Patients with infection at the injection site
* Coagulopathy Allergy to amide-type local anesthetics
* History of peripheral neuropathy
* Hepatic and/or renal failure
* Refusing the procedure
* Patients with heart disease
* Patients who have previously undergone surgery from the same area
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Gökçe Gişi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gökce Gişi

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam Universty

Gözen Öksüz

Role: STUDY_DIRECTOR

Kahramanmaras Sutcu Imam Universty

Locations

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Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2020/12-04

Identifier Type: -

Identifier Source: org_study_id

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