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

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: Completed
• Conditions: Pain, Postoperative; Anesthesia, Local; Anesthesia, Regional; Spinal Disease
• Intervention / Treatment: Other: Visual Analog Score; Other: patient satisfaction

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: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual Analog Score	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

Outcome Measure	Measure Description	Time Frame
patient satisfaction	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

• Sponsor: Trakya University
• Investigators: Principal Investigator: SEVTAP HEKİMOĞLU ŞAHİN, Professor, Trakya University; Principal Investigator: ONUR KÜÇÜK, Resident, Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: spinal surgery; ultrasound-guided bilateral erector spina plane block; wound infiltration analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Pain, Postoperative; Spinal Diseases
• Other Study ID 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