Hip SurgeryL-ESP-HIP StudNCT07427082
Comparison of Lumbar Erector Spinae Plane Block and Spinal Anesthesia in Hip and Proximal Femur Surgery
A study testing Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4) and Spinal Anesthesia (L4-L5) in people with Hip Surgery and Femoral Neck Fractures, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hip and proximal femur surgeries are commonly performed in elderly patients and require anesthetic techniques that provide adequate surgical anesthesia while minimizing the need for additional opioid administration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Surgery, Femoral Neck Fractures
- What is being tested?
- Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4) and Spinal Anesthesia (L4-L5)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2022to 1 Sep 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Patients diagnosed with hip fracture requiring surgical intervention
- Patients diagnosed with proximal femur fracture requiring surgical intervention
Who cannot join
- Known allergy to local anesthetic agents
- Patients younger than 18 years or older than 80 years
- American Society of Anesthesiologists (ASA) physical status IV or higher
- Lumbar skeletal deformity or history of previous lumbar spine surgery
- Contraindications to regional anesthesia (e.g., coagulopathy, infection at the injection site, severe hypovolemia, patient refusal)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and Safety Between Ultrasound-Guided L4 Level Lumbar Erector Spinae Plane Block and Spinal Anesthesia in Hip and Proximal Femur Surgery
Hip and proximal femur surgeries are commonly performed in elderly patients and require anesthetic techniques that provide adequate surgical anesthesia while minimizing the need for additional opioid administration. Spinal anesthesia is widely used for these procedures; however, it may be associated with intraoperative opioid requirements and hemodynamic changes. The lumbar erector spinae plane (ESP) block is a regional anesthesia technique that may be used as an alternative anesthetic approach in hip and proximal femur surgery.
This prospective, randomized, single-blind study compares ultrasound-guided lumbar erector spinae plane block performed at the L4 level with spinal anesthesia in patients undergoing hip and proximal femur surgery. A total of 68 adult patients with ASA physical status I-III were allocated to receive either lumbar ESP block or spinal anesthesia. All patients received standardized premedication consisting of intravenous midazolam 2 mg and fentanyl 100 µg.
The study evaluated the applied anesthetic technique, intraoperative opioid use and the time to first postoperative rescue analgesic administration. Patients in whom adequate anesthesia could not be achieved with the assigned technique and required conversion to general anesthesia were excluded from the final analysis. The results of this study may help determine whether lumbar ESP block is a feasible and safe alternative to spinal anesthesia in hip and proximal femur surgeries.
Read the detailed description
Hip and proximal femur surgeries are frequently performed in elderly patients and require anesthetic techniques that provide sufficient surgical anesthesia while limiting the need for additional intraoperative opioid administration. In this patient population, selecting an appropriate anesthetic approach is particularly important due to age-related physiological changes and the presence of comorbidities.
This study was designed as a prospective, randomized, single-blind clinical trial comparing ultrasound-guided lumbar erector spinae plane (ESP) block performed at the L4 vertebral level with spinal anesthesia in patients undergoing hip and proximal femur surgery. After obtaining written informed consent, eligible adult patients were randomly assigned to one of the two anesthetic techniques using a computer-generated randomization sequence. Intraoperative assessments were performed by an investigator who was blinded to group allocation.
All patients received standardized premedication consisting of intravenous midazolam 2 mg and fentanyl 100 µg prior to the anesthetic procedure. In the spinal anesthesia group, spinal anesthesia was performed at the L4-L5 interspace according to institutional routine practice. In the ESP block group, an ultrasound-guided erector spinae plane block was performed at the L4 level using a total volume of 30 mL of local anesthetic solution, composed of 15 mL of 0.5% isobaric bupivacaine, 7.5 mL of 2% lidocaine, and 7.5 mL of normal saline.
Standard intraoperative monitoring, including electrocardiography, non-invasive blood pressure measurement, and peripheral oxygen saturation, was applied to all patients throughout the surgical procedure. The adequacy of anesthesia was evaluated intraoperatively based on clinical signs and the requirement for additional opioid administration. Intraoperative opioid use was recorded as present or absent and documented.
When inadequate anesthesia or analgesia was observed, rescue opioid analgesia was administered according to a standardized institutional protocol. Patients in whom adequate anesthesia could not be achieved with the assigned technique and who required conversion to general anesthesia were excluded from the final analysis.
The primary parameters evaluated in this study included the anesthetic technique applied (lumbar ESP block or spinal anesthesia), intraoperative opioid use and the time to first postoperative rescue analgesic administration. This study aims to provide clinical data on whether lumbar ESP block can be used as an effective and safe alternative to spinal anesthesia in hip and proximal femur surgery.
- Conditions
- Hip Surgery, Femoral Neck Fractures
- Being tested
- Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4), Spinal Anesthesia (L4-L5)
- Keywords
- Erector Spinae Plane Block, Lumbar ESP Block, Ultrasound-Guided Regional Anesthesia, Spinal Anesthesia, Hip Fracture, Proximal Femur Fracture, Hip Surgery, Intraoperative Opioid Consumption, Intraoperative Opioid Requirement, Rescue Analgesia Time, Single-Blind Randomized Trial
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures, Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4)Procedure or surgery
Ultrasound-guided lumbar erector spinae plane (ESP) block performed at the L4 level using a total of 30 mL local anesthetic solution (15 mL 0.5% isobaric bupivacaine + 7.5 mL 2% lidocaine + 7.5 mL 0.9% NaCl). All participants receive standardized premedication with midazolam 2 mg IV and fentanyl 100 µg IV prior to the procedure. Intraoperative opioid requirement/consumption and time to first postoperative rescue analgesic administration are recorded. Participants requiring conversion to general anesthesia due to inadequate anesthesia are considered block failures and are excluded from final analysis.
Spinal Anesthesia (L4-L5)Procedure or surgery
Spinal anesthesia performed at the L4-L5 interspace according to institutional routine practice. All participants receive standardized premedication with midazolam 2 mg IV and fentanyl 100 µg IV prior to the procedure. Intraoperative opioid requirement/consumption and time to first postoperative rescue analgesic administration are recorded.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar ESP Block (L4, Ultrasound-Guided) | Experimental | Participants receive an ultrasound-guided lumbar erector spinae plane (ESP) block at the L4 level using a total of 30 mL local anesthetic solution (15 mL 0.5% isobaric bupivacaine + 7.5 mL 2% lidocaine + 7.5 mL 0.9% NaCl). Standard premedication is administered to all participants (midazolam 2 mg IV and fentanyl 100 µg IV). Inadequate anesthesia requiring conversion to general anesthesia is considered block failure and those participants are excluded from final analysis. Receives: Procedure: Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4) |
| Spinal Anesthesia (L4-L5) | Active comparator | Participants receive spinal anesthesia at the L4-L5 interspace according to institutional routine practice (e.g., intrathecal bupivacaine). Standard premedication is administered to all participants (midazolam 2 mg IV and fentanyl 100 µg IV). Intraoperative opioid requirement/consumption and time to first postoperative rescue analgesic administration are recorded. Receives: Procedure: Spinal Anesthesia (L4-L5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Postoperative Rescue Analgesia
Time elapsed from the end of surgery until the first postoperative rescue analgesic is administered. Rescue analgesia is given according to the institutional protocol when clinically indicated.
Measured: From the end of surgery to the first administration of rescue analgesic (up to 24 hours)
Secondary outcomes (2)
Intraoperative Opioid Requirement (Yes/No)
Whether additional intraoperative opioid was required for inadequate analgesia (recorded as yes/no) beyond standardized premedication.
Measured: During surgery (from start of surgery to end of surgery)
Incidence of intraoperative hypotension
>20% decrease from baseline mean arterial pressure
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Aug 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel groups (ultrasound-guided L4 lumbar ESP block or spinal anesthesia) and received only the assigned intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Gökhan Abay, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427082
- Sponsor's protocol ID
- 190
- Acronym
- L-ESP-HIP Stud
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
PubMed 32158307
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between Ultrasound-Guided L4 Level Lumbar Erector Spinae Plane Block and Spinal Anesthesia in Hip and Proximal Femur Surgery
- ClinicalTrials.gov ID
- NCT07427082
- Acronym / sponsor ID
- L-ESP-HIP Stud / 190
- Conditions
- Hip Surgery, Femoral Neck Fractures
- Keywords
- Erector Spinae Plane Block, Lumbar ESP Block, Ultrasound-Guided Regional Anesthesia, Spinal Anesthesia, Hip Fracture, Proximal Femur Fracture, Hip Surgery, Intraoperative Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Feb 2026 (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.
Hip and proximal femur surgeries are commonly performed in elderly patients and require anesthetic techniques that provide adequate surgical anesthesia while minimizing the need for additional opioid administration. Spinal anesthesia is widely used for these procedures; however, it may be associated with intraoperative opioid requirements and hemodynamic changes. The lumbar erector spinae plane (ESP) block is a regional anesthesia technique that may be used as an alternative anesthetic approach in hip and proximal femur surgery.
This prospective, randomized, single-blind study compares ultrasound-guided lumbar erector spinae plane block performed at the L4 level with spinal anesthesia in patients undergoing hip and proximal femur surgery. A total of 68 adult patients with ASA physical status I-III were allocated to receive either lumbar ESP block or spinal anesthesia. All patients received standardized premedication consisting of intravenous midazolam 2 mg and fentanyl 100 µg.
The study evaluated the applied anesthetic technique, intraoperative opioid use and the time to first postoperative rescue analgesic administration. Patients in whom adequate anesthesia could not be achieved with the assigned technique and required conversion to general anesthesia were excluded from the final analysis. The results of this study may help determine whether lumbar ESP block is a feasible and safe alternative to spinal anesthesia in hip and proximal femur surgeries.
Detailed description
Hip and proximal femur surgeries are frequently performed in elderly patients and require anesthetic techniques that provide sufficient surgical anesthesia while limiting the need for additional intraoperative opioid administration. In this patient population, selecting an appropriate anesthetic approach is particularly important due to age-related physiological changes and the presence of comorbidities.
This study was designed as a prospective, randomized, single-blind clinical trial comparing ultrasound-guided lumbar erector spinae plane (ESP) block performed at the L4 vertebral level with spinal anesthesia in patients undergoing hip and proximal femur surgery. After obtaining written informed consent, eligible adult patients were randomly assigned to one of the two anesthetic techniques using a computer-generated randomization sequence. Intraoperative assessments were performed by an investigator who was blinded to group allocation.
All patients received standardized premedication consisting of intravenous midazolam 2 mg and fentanyl 100 µg prior to the anesthetic procedure. In the spinal anesthesia group, spinal anesthesia was performed at the L4-L5 interspace according to institutional routine practice. In the ESP block group, an ultrasound-guided erector spinae plane block was performed at the L4 level using a total volume of 30 mL of local anesthetic solution, composed of 15 mL of 0.5% isobaric bupivacaine, 7.5 mL of 2% lidocaine, and 7.5 mL of normal saline.
Standard intraoperative monitoring, including electrocardiography, non-invasive blood pressure measurement, and peripheral oxygen saturation, was applied to all patients throughout the surgical procedure. The adequacy of anesthesia was evaluated intraoperatively based on clinical signs and the requirement for additional opioid administration. Intraoperative opioid use was recorded as present or absent and documented.
When inadequate anesthesia or analgesia was observed, rescue opioid analgesia was administered according to a standardized institutional protocol. Patients in whom adequate anesthesia could not be achieved with the assigned technique and who required conversion to general anesthesia were excluded from the final analysis.
The primary parameters evaluated in this study included the anesthetic technique applied (lumbar ESP block or spinal anesthesia), intraoperative opioid use and the time to first postoperative rescue analgesic administration. This study aims to provide clinical data on whether lumbar ESP block can be used as an effective and safe alternative to spinal anesthesia in hip and proximal femur surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel groups (ultrasound-guided L4 lumbar ESP block or spinal anesthesia) and received only the assigned intervention.
| Arm | Type | Receives |
|---|---|---|
| Lumbar ESP Block (L4, Ultrasound-Guided) | Experimental | Procedure: Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4)Participants receive an ultrasound-guided lumbar erector spinae plane (ESP) block at the L4 level using a total of 30 mL local anesthetic solution (15 mL 0.5% isobaric bupivacaine + 7.5 mL 2% lidocaine + 7.5 mL 0.9% NaCl). Standard premedication is administered to all participants (midazolam 2 mg IV and fentanyl 100 µg IV). Inadequate anesthesia requiring conversion to general anesthesia is considered block failure and those participants are excluded from final analysis. |
| Spinal Anesthesia (L4-L5) | Active comparator | Procedure: Spinal Anesthesia (L4-L5)Participants receive spinal anesthesia at the L4-L5 interspace according to institutional routine practice (e.g., intrathecal bupivacaine). Standard premedication is administered to all participants (midazolam 2 mg IV and fentanyl 100 µg IV). Intraoperative opioid requirement/consumption and time to first postoperative rescue analgesic administration are recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Patients diagnosed with hip fracture requiring surgical intervention
- Patients diagnosed with proximal femur fracture requiring surgical intervention
Key exclusion criteria (6 listed)
- Known allergy to local anesthetic agents
- Patients younger than 18 years or older than 80 years
- American Society of Anesthesiologists (ASA) physical status IV or higher
- Lumbar skeletal deformity or history of previous lumbar spine surgery
- Contraindications to regional anesthesia (e.g., coagulopathy, infection at the injection site, severe hypovolemia, patient refusal)
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 |
|---|---|---|
| Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4)Ultrasound-guided lumbar erector spinae plane (ESP) block performed at the L4 level using a total of 30 mL local anesthetic solution (15 mL 0.5% isobaric bupivacaine + 7.5 mL 2% lidocaine + 7.5 mL 0.9% NaCl). All participants receive standardized premedication with midazolam 2 mg IV and fentanyl 100 µg IV prior to the procedure. Intraoperative opioid requirement/consumption and time to first postoperative rescue analgesic administration are recorded. Participants requiring conversion to general anesthesia due to inadequate anesthesia are considered block failures and are excluded from final analysis. | Procedure or surgery | Lumbar ESP Block (L4, Ultrasound-Guided) |
| Spinal Anesthesia (L4-L5)Spinal anesthesia performed at the L4-L5 interspace according to institutional routine practice. All participants receive standardized premedication with midazolam 2 mg IV and fentanyl 100 µg IV prior to the procedure. Intraoperative opioid requirement/consumption and time to first postoperative rescue analgesic administration are recorded. | Procedure or surgery | Spinal Anesthesia (L4-L5) |
Primary outcome
Time to First Postoperative Rescue Analgesia
Time frame: From the end of surgery to the first administration of rescue analgesic (up to 24 hours)
Time elapsed from the end of surgery until the first postoperative rescue analgesic is administered. Rescue analgesia is given according to the institutional protocol when clinically indicated.
2 secondary outcomes
Intraoperative Opioid Requirement (Yes/No)
Time frame: During surgery (from start of surgery to end of surgery)
Incidence of intraoperative hypotension
Time frame: Intraoperative period
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 19 Oct 2026.
- Background: PubMed 32158307Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
- Individual participant dataSharing planned: No
Related trials for Hip Surgery
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4) and Spinal Anesthesia (L4-L5) in people with Hip Surgery and Femoral Neck Fractures, run by Gaziantep City Hospital 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 4 inclusion and 6 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 19 Oct 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?
Time to First Postoperative Rescue Analgesia (time frame: From the end of surgery to the first administration of rescue analgesic (up to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427082, which also lists 1 linked publication.
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 19 Oct 2026.