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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642625
• Other study ID #: TÜTF-BAEK 2020/183
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Anesthesia, Regional
• Pain, Postoperative
• Spinal Disease
• Spinal Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne	Centrum

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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