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Completed

NCT Number: NCT04642625

Comparison of Ultrasound-guided Bilateral ESP 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.

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Key information

Conditions

Pain, Postoperative Anesthesia, Local Anesthesia, Regional Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Disease Spinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual Analog Score

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".

Other names: VAS

Patient Satisfaction

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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