Comparison of Lumbar Erector Spinae Plane Block and Spinal Anesthesia in Hip and Proximal Femur Surgery

NCT07427082 | Completed

• 1 other identifier: 190
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Intraoperative Opioid Requirement; Rescue Analgesia Time; Single-Blind Randomized Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  From the end of surgery to the first administration of rescue analgesic (up to 24 hours)

Secondary Outcomes (2)

• Intraoperative Opioid Requirement (Yes/No)

  During surgery (from start of surgery to end of surgery)

• Incidence of intraoperative hypotension

  Intraoperative period

Study Arms (2)

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.

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.

Procedure: Spinal Anesthesia (L4-L5)

Interventions

Ultrasound-Guided Lumbar Erector Spinae Plane Block (L4) PROCEDURE

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.

Lumbar ESP Block (L4, Ultrasound-Guided)

Spinal Anesthesia (L4-L5) PROCEDURE

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.

Spinal Anesthesia (L4-L5)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32158307 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures; Proximal Femoral Fractures

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments and data recording were performed by an investigator blinded to group allocation; the anesthesiologist performing the procedure was not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)