Comparison of Ultrasound-guided Bilateral ESP Block and Wound Infiltration for Spinal Surgical Analgesia

January 17, 2023 updated by: Onur Kucuk, Trakya University

Comparison of Ultrasound-guided Bilateral Erector Spinae Plane Block and Wound Infiltration for Spinal Surgical Analgesia

The aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. In this study, patient data will be collected in the form of file scanning. Intra-operative; hemodynamic data of patients; heart rate, blood pressure values, anesthetic and other drugs applied, surgery and anesthesia durations will be written from the anesthesia document after the operation is over. In the study, the application preferred by the anesthesiologist for the patient will not be intervened. The patients will be divided into three groups; wound infiltration technique was applied, ultrasound-guided bilateral erector spina plan block technique was applied and both techniques were applied together. After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients. The patient's length of stay, satisfaction (excellent, good, moderate, poor) and methods used for analgesia will be recorded. With the results collected in our study, it will be determined which procedure is superior in pain management for spine surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Centrum
      • Edirne, Centrum, Turkey, 22030
        • Trakya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. 75 patients meeting these conditions will be included in the study.

Description

Inclusion Criteria:

  • Undergoing elective spine surgery
  • No contraindication to the technique to be applied
  • Not pregnant
  • Being over the age of 18

Exclusion Criteria:

  • Undergoing emergency spine surgery
  • There is an obstacle to the technical process to be applied
  • Pregnant patients
  • Patients younger than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
wound infiltration analgesia
25 patients who underwent wound infiltration analgesia
Other: Visual Analog Score
The VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of "severe pain".
Other Names:
  • VAS
Other: patient satisfaction
The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
ultrasound-guided bilateral erector spina plan block analgesia
25 patients who underwent ultrasound-guided bilateral erector spina plan block analgesia
Other: Visual Analog Score
The VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of "severe pain".
Other Names:
  • VAS
Other: patient satisfaction
The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together
25 patients who underwent wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia
Other: Visual Analog Score
The VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of "severe pain".
Other Names:
  • VAS
Other: patient satisfaction
The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Score
Time Frame: postoperative 24 hours score change
It consists of a 100mm line. 0cm no pain, 10cm is associated with 'worst possible pain'. The patient is asked to mark a line to 'score' the pain. VAS values of 1cm-3cm weak, 4cm-6cm moderate, and >7cm are the indicators of "severe pain".After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients.
postoperative 24 hours score change

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: postoperative 24 hours score change
The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
postoperative 24 hours score change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trakya University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVTAP HEKİMOĞLU ŞAHİN, Professor, Trakya University
  • Principal Investigator: ONUR KÜÇÜK, Resident, Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TÜTF-BAEK 2020/183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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