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

NCT04642625 | Completed DMC

• 1 other identifier: TÜTF-BAEK 2020/183
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Spinal Disease; Anesthesia, Local; Anesthesia, Regional

Keywords

ultrasound-guided bilateral erector spina plane block; wound infiltration analgesia; spinal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• patient satisfaction

  postoperative 24 hours score change

Study Arms (3)

wound infiltration analgesia

25 patients who underwent wound infiltration analgesia

Other: Visual Analog Score; Other: patient satisfaction

ultrasound-guided bilateral erector spina plan block analgesia

25 patients who underwent ultrasound-guided bilateral erector spina plan block analgesia

Other: Visual Analog Score; Other: patient satisfaction

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; Other: patient satisfaction

Interventions

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".

Also known as: VAS

ultrasound-guided bilateral erector spina plan block analgesia; wound infiltration analgesia; wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together

patient satisfaction 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; wound infiltration analgesia; wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Undergoing elective spine surgery
• No contraindication to the technique to be applied
• Not pregnant
• Being over the age of 18

You may not qualify if:

• Undergoing emergency spine surgery
• There is an obstacle to the technical process to be applied
• Pregnant patients
• Patients younger than 18 years old

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Spinal Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• SEVTAP HEKİMOĞLU ŞAHİN, Professor

  Trakya University

  PRINCIPAL INVESTIGATOR

• ONUR KÜÇÜK, Resident

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation, Research Assistant

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 24, 2020
• Study Start: April 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)