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

Completed

• Conditions: Pain, Postoperative; Spinal Disease; Anesthesia, Regional; Anesthesia, Local
• Interventions: Other: Visual Analog Score; Other: patient satisfaction

• Registration Number: NCT04642625
• Lead Sponsor: Trakya University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-11-24
• Study Start: 2021-04-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together	Visual Analog Score	25 patients who underwent wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia
wound infiltration analgesia	Visual Analog Score	25 patients who underwent wound infiltration analgesia
ultrasound-guided bilateral erector spina plan block analgesia	Visual Analog Score	25 patients who underwent ultrasound-guided bilateral erector spina plan block analgesia
ultrasound-guided bilateral erector spina plan block analgesia	patient satisfaction	25 patients who underwent ultrasound-guided bilateral erector spina plan block analgesia
wound infiltration analgesia	patient satisfaction	25 patients who underwent wound infiltration analgesia
wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together	patient satisfaction	25 patients who underwent wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia

Primary Outcome Measures

Name	Time	Method
Visual Analog Score	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 Outcome Measures

Name	Time	Method
patient satisfaction	postoperative 24 hours score change	The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Centrum, Turkey