Viewing Study NCT06652334



Ignite Creation Date: 2024-10-25 @ 7:51 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06652334
Status: RECRUITING
Last Update Posted: None
First Post: 2024-10-17

Brief Title: Comparison of Spinal Anesthesia and Erector Spinae Plane Block in Critically Adult Patients Undergoing Femur Surgery
Sponsor: None
Organization: None

Study Overview

Official Title: Comparison of Spinal Anesthesia and Erector Spinae Plane Block in Terms of Pain Management Perioperative Hemodynamic Changes Morbidity and Mortality in Critically Adult Patients Undergoing Surgery Due to Femur Fracture
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this observational study is to compare the regional anesthetic methods not including general anesthesia -spinal anesthesia erector spinae plane ESP block- which are in routine practice in critically ill adult patients operated for femur fracture in terms of intraoperative and postoperative hemodynamics and clinical course postoperative intensive care unit stay and hospitalization durations pain scores postoperative morbidity and mortality

Participants will undergo either spinal anesthesia or erector spinae plane block
Detailed Description: Different anesthesia methods including general and regional anesthesia are used in operating rooms in daily practice When general anesthesia is performed the patient is rendered entirely unconscious by using intravenous andor inhalation anesthetics total sensory loss develops and the patients ventilation is provided by a mechanical ventilator Regional anesthesia applications consist of blockage of nerve conduction by applying local anesthetics from different body parts without causing loss of consciousness By using neuraxial anesthesia techniques - such as spinal anesthesia epidural anesthesia and caudal block - medulla spinalis-related neuronal blocking can be performed Another regional anesthesia method whose use has expanded considerably in recent years is peripheral nerve blocks This anesthesia method injects local anesthetic by targeting a specific plexus nerve or facia without any central nervous system blockage

An essential part of intraoperative anesthesia management is planning analgesia for postoperative pain It is aimed to provide analgesia with intravenous analgesics central neuraxial blocks or peripheral nerve blocks Ensuring postoperative pain management has great importance in clinical practice because pain is associated with the patients superficial breathing prolonged immobilization and noncompliant patients Therefore it is related to the development of atelectasis in the postoperative period andor hypoxia-hypercarbia caused by inadequate gas exchange In this situation where the patient cannot provide adequate respiration the need for noninvasive mechanical ventilation may develop in the ward or intensive care unit where the patient is followed closer clinical follow-up will be required and the patients hospitalization period will be prolonged For this reason it is one of the primary responsibilities to prefer anesthetic methods that help to provide optimal postoperative pain management

Femoral fracture cases are primarily encountered in elderly patients with multiple comorbidities Postoperative follow-up of these highly mortal fractures is often provided in intensive care units In Turkish society with an increasing elderly population the long hospitalization periods of this patient group in the intensive care unit and their subsequent follow-up in the ward until they are discharged bring high healthcare costs It has been shown in various studies in the literature that the anesthetic method is related to the length of hospitalization Therefore the clinical practices of anesthesiologists who frequently work with elderly patients in the operating room and intensive care are essential

The clinician chooses the method of anesthesia taking into account the type of operation contraindications of the patients clinical condition pain management postoperative follow-up conditions and patient request In critically ill patients with femoral fractures the surgical procedure is successfully performed under general anesthesia spinal anesthesia or lumbar erector spinae plane ESP block There are studies in which erector spinae plane ESP block applied from the lumbar region has been used as a primary anesthetic method that allows surgery in patients with femoral fractures

In this study the investigators aimed to compare the regional anesthetic methods not including general anesthesia -spinal anesthesia erector spinae plane ESP block- which are in routine practice in critically ill adult patients operated for femur fracture in terms of intraoperative and postoperative hemodynamics and clinical course postoperative intensive care unit stay and hospitalization durations pain scores postoperative morbidity and mortality

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None