- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427082
Comparison of Lumbar Erector Spinae Plane Block and Spinal Anesthesia in Hip and Proximal Femur Surgery (L-ESP-HIP Stud)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey (Türkiye)
- Gaziantep University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lumbar ESP Block (L4, Ultrasound-Guided)
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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From the end of surgery to the first administration of rescue analgesic (up to 24 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Opioid Requirement (Yes/No)
Time Frame: During surgery (from start of surgery to end of surgery)
|
Whether additional intraoperative opioid was required for inadequate analgesia (recorded as yes/no) beyond standardized premedication.
|
During surgery (from start of surgery to end of surgery)
|
|
Incidence of intraoperative hypotension
Time Frame: Intraoperative period
|
>20% decrease from baseline mean arterial pressure
|
Intraoperative period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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