Clinical trial NCT06652334: Comparison of Spinal Anesthesia and Erector Spinae Plane Block in Critically Adult Patients Undergoing Femur Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Fractures
Keywords: Anesthesia, Spinal
Geriatric Anesthesia
Anesthesia and Analgesia
Nerve Block
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: After the patients who meet the specified criteria are informed about the study, 40 volunteers who agree to participate and sign an informed consent form will be included in the study.

Volunteers will be randomized into 2 groups using a closed-envelope method. Group 1 will contain patients operated under spinal anesthesia, and Group 2 will contain patients operated under ESP block.

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 and/or inhalation anesthetics, total sensory loss develops, and the patient's 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 patient's superficial breathing, prolonged immobilization, and noncompliant patients. Therefore, it is related to the development of atelectasis in the postoperative period and/or 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 patient's 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 patient's 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.

Eligibility criteria: Inclusion Criteria:

* Agree to participate in the study
* Patients older than 65 years of age who are planning to undergo an operation for a femur fracture and who are in the ASA III and above risk group and for whom postoperative intensive care unit follow-up is foreseen
* Patients who agree to be operated under regional anesthesia

Exclusion Criteria:

* Patients who did not want to be included in the study
* Patients considered suitable for operation under general anesthesia
* Patients allergic to bupivacaine
* Patients with contraindications to neuraxial blockage (infection at the injection site, coagulopathy or other bleeding diathesis, severe hypovolemia, increased intracranial pressure, severe aortic stenosis, severe mitral stenosis)

Primary outcomes:
measure: Pain scores
timeFrame: The VAS scores of the patients will be evaluated preoperatively, at 1 hour, 6 hours, 12 hours and 24 hours postoperatively.
measure: Intraoperative sedation
timeFrame: The total dose of sedatives used along the operation will be calculated one time immediately at the end of the operation
measure: Intensive care unit length of stay
timeFrame: Through study completion, an average of 24 months.The intensive care unit length of stay will be calculated one time at the end of the intensive care unit stay, immediately at the timepoint of intensive care unit discharge.
measure: Hospital length of stay
timeFrame: Through study completion, an average of 24 months.The ihospital length of stay will be calculated one time at the end of the hospital stay, immediately at the timepoint of the hospital discharge.
measure: Complications in the Intensive Care Unit
timeFrame: Complications will be recorded 1 time per day along the intensive care unit stay up to 90th day postoperatively.
measure: Mortality
timeFrame: Mortality will be recorded 4 times up to 90th day postoperatively.: 1- at the time of discharge from the Intensive care unit, 2-at the time of discharge from the hospital 3- on the postoperative 30th day, 4- Mortality on the postoperative90th day
Secondary outcomes:
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce University Faculty of Medicine
state: Düzce
Study officials:
affiliation: Düzce University Faculty of Medicine
name: Özlem Ersoy Karka, Ass. Prof.
role: STUDY_DIRECTOR
References: