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

NCT ID: NCT04642625

Last Updated: 2023-01-19

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

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative Spinal Disease Anesthesia, Local Anesthesia, Regional

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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wound infiltration analgesia

25 patients who underwent wound infiltration analgesia

Visual Analog Score

Intervention Type OTHER

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".

patient satisfaction

Intervention Type OTHER

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

Visual Analog Score

Intervention Type OTHER

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".

patient satisfaction

Intervention Type OTHER

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

Visual Analog Score

Intervention Type OTHER

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".

patient satisfaction

Intervention Type OTHER

The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.

Interventions

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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".

Intervention Type OTHER

patient satisfaction

The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.

Intervention Type OTHER

Other Intervention Names

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VAS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Onur Kucuk

Department of anesthesiology and reanimation, Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SEVTAP HEKİMOĞLU ŞAHİN, Professor

Role: PRINCIPAL_INVESTIGATOR

Trakya University

ONUR KÜÇÜK, Resident

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

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Trakya University

Edirne, Centrum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TÜTF-BAEK 2020/183

Identifier Type: -

Identifier Source: org_study_id

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