Comparison of Spinal Anesthesia and Erector Spinae Plane Block in Critically Adult Patients Undergoing Femur Surgery

NCT06652334 | Completed

• 1 other identifier: drozlemersoy5
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fractures

Keywords

Anesthesia, Spinal; Geriatric Anesthesia; Anesthesia and Analgesia; Nerve Block

Outcome Measures

Primary Outcomes (6)

• Pain scores

  The Visual Analog Scale (VAS) is planned to be used for pain scoring. It will assess the severity of patients' pain in the preoperative and postoperative periods. It will be administered using a 10-centimeter line, with the words "no pain" on one side and "most severe pain" on the other. Patients will be asked to place a mark along the line at a level representing the intensity of their pain, which will then be measured in cm. The mark at 0 cm means "no pain," and the mark at 10 cm represents "the most severe pain the patient has ever sensed." Higher VAS scores mean the worst outcome. The patients' VAS scores will be evaluated preoperatively, at 1 hour, 6 hours, 12 hours, and 24 hours postoperatively.

  The VAS scores of the patients will be evaluated preoperatively, at 1 hour, 6 hours, 12 hours and 24 hours postoperatively.

• Intraoperative sedation

  The total dose of sedatives used along the operation to maintain a BIS value between 80-90.

  The total dose of sedatives used along the operation will be calculated one time immediately at the end of the operation

• Intensive care unit length of stay

  Time from end of the operation to discharge of the intensive care unit

  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.

• Hospital length of stay

  Time from discharge of the intensive care unit to discharge of the hospital

  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.

• Complications in the Intensive Care Unit

  Clinical course - if any need for noninvasive/invasive mechanical ventilation, need for oxygen support, need for inotropes, development of acute kidney injury, state of consciousness, or additional complications- will be monitored and recorded at ICU (Intensive Care Unit).

  Complications will be recorded 1 time per day along the intensive care unit stay up to 90th day postoperatively.

• Mortality

  In-hospital mortality, Intensive care mortality and Mortality after discharge. Patients will be followed up by telephone contact for mortality on the 30th and 90th postoperative days after discharge.

  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

Study Arms (2)

Spinal anesthesia

20 patients undergoing spinal anesthesia

Procedure: Spinal anesthesia

Erector spinae plane block

20 patients undergoing erector spinae plane block

Procedure: Erector spinae plane block

Interventions

Spinal anesthesia PROCEDURE

20 patients undergoing spinal anesthesia

Spinal anesthesia

Erector spinae plane block PROCEDURE

20 patients undergoing erector spinae plane block

Erector spinae plane block

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Medicine

Düzce, Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Fractures; Agnosia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Özlem Ersoy Karka, Ass. Prof.

  Düzce University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: October 20, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

TU (1)