Femoral FracturesNCT06652334
Comparison of Spinal Anesthesia and Erector Spinae Plane Block in Critically Adult Patients Undergoing Femur Surgery
An observational study of Femoral Fractures, run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Spinal anesthesia and Erector spinae plane block
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Medicine
Düzce, Düzce, 81000
About this study
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
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.
Read the 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.
- Conditions
- Femoral Fractures
- Being tested
- Spinal anesthesia, Erector spinae plane block
- Keywords
- Anesthesia, Spinal, Geriatric Anesthesia, Anesthesia and Analgesia, Nerve Block
- Medical subject headings
- Femoral Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Spinal anesthesia was performed at the L3-L4 or L4-L5 intervertebral space using intrathecal hyperbaric bupivacaine. After confirmation of adequate sensory block, propofol sedation was titrated to maintain a BIS value between 80 and 90.
Erector spinae plane blockProcedure or surgery
Ultrasound-guided lumbar erector spinae plane block was performed at the L4 level using a total volume of 30 mL local anesthetic solution consisting of bupivacaine, lidocaine, and normal saline. After confirmation of adequate sensory block, propofol sedation was titrated to maintain a BIS value between 80 and 90.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | 20 patients undergoing spinal anesthesia Receives: Procedure: Spinal anesthesia | |
| Erector spinae plane block | 20 patients undergoing erector spinae plane block Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hemodynamic profile
Intraoperative systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, and heart rate were recorded at 5-minute intervals throughout surgery to evaluate perioperative hemodynamic changes between the two regional anesthetic techniques.
Measured: From the beginning of intraoperative monitoring until the end of surgery, assessed at 5-minute intervals.
Secondary 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.
Measured: 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.
Measured: The total dose of sedatives used along the operation will be calculated one time immediately at the end of the operation
Mortality
Mortality was assessed during intensive care unit and hospital stay and after discharge. Post-discharge mortality was assessed by telephone follow-up on postoperative days 30 and 90.
Measured: 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
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).
Measured: Complications will be recorded 1 time per day along the intensive care unit stay up to 90th day postoperatively.
Hospital length of stay
Time from discharge from the intensive care unit to discharge from the hospital, measured in days.
Measured: From intensive care unit discharge to hospital discharge.
Intensive care unit length of stay
Time from end of the operation to discharge of the intensive care unit
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Mar 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ersoy Karka, Duzce University
- Investigators
- Özlem Ersoy Karka, Ass. Prof., Study director, Düzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652334
- Sponsor's protocol ID
- drozlemersoy5
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06652334
- Acronym / sponsor ID
- drozlemersoy5
- Conditions
- Femoral Fractures
- Keywords
- Anesthesia, Spinal, Geriatric Anesthesia, Anesthesia and Analgesia, Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | – | Procedure: Spinal anesthesia20 patients undergoing spinal anesthesia |
| Erector spinae plane block | – | Procedure: Erector spinae plane block20 patients undergoing erector spinae plane block |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaSpinal anesthesia was performed at the L3-L4 or L4-L5 intervertebral space using intrathecal hyperbaric bupivacaine. After confirmation of adequate sensory block, propofol sedation was titrated to maintain a BIS value between 80 and 90. | Procedure or surgery | Spinal anesthesia |
| Erector spinae plane blockUltrasound-guided lumbar erector spinae plane block was performed at the L4 level using a total volume of 30 mL local anesthetic solution consisting of bupivacaine, lidocaine, and normal saline. After confirmation of adequate sensory block, propofol sedation was titrated to maintain a BIS value between 80 and 90. | Procedure or surgery | Erector spinae plane block |
Primary outcome
Intraoperative hemodynamic profile
Time frame: From the beginning of intraoperative monitoring until the end of surgery, assessed at 5-minute intervals.
Intraoperative systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, and heart rate were recorded at 5-minute intervals throughout surgery to evaluate perioperative hemodynamic changes between the two regional anesthetic techniques.
6 secondary outcomes
Pain scores
Time frame: The VAS scores of the patients will be evaluated preoperatively, at 1 hour, 6 hours, 12 hours and 24 hours postoperatively.
Intraoperative sedation
Time frame: The total dose of sedatives used along the operation will be calculated one time immediately at the end of the operation
Mortality
Time frame: 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
Complications in the Intensive Care Unit
Time frame: Complications will be recorded 1 time per day along the intensive care unit stay up to 90th day postoperatively.
Hospital length of stay
Time frame: From intensive care unit discharge to hospital discharge.
Intensive care unit length of stay
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Ersoy Karka, Ass. Prof. study director
Düzce University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fractures, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative hemodynamic profile (time frame: From the beginning of intraoperative monitoring until the end of surgery, assessed at 5-minute intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.