Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery

NCT06567522 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ESPL - MORFINA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities. When faced with this patient profile, there is a tendency to undertreat pain for fear of the side effects and pharmacological interactions of conventional analgesic drugs. Ultrasound-guided regional anesthesia applied in orthopedic and trauma surgery has been shown to reduce the doses of opioids and conventional analgesics, to ease deambulation and early recovery, to improve respiratory dynamics and to reduce vein thrombosis and pneumonias. Our study aims to verify whether L-ESP block is effective in the hip and proximal femur surgeries and allows to lower the dosage of opioids in these patients.

Conditions

Hip Fractures; Lumbar Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• To compare the analgesic effectiveness and safety of lumbar ESP block versus absence of block after hip and proximal femur surgeries by means of the VAS scale with pain reduction of at least 1 point in the first two hours after surgery.

  Collect data on post-surgery pain using the Visual Analogue Scale (VAS).The VAS scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.

  2 hours after surgery

Secondary Outcomes (4)

• Compare the analgesic postoperative needs after performing L-ESP block versus a control group of patients having undergone hip or proximal femur surgeries and the postoperative consumption of opioids in both groups

  12 hours postoperative

• Percentage of patients with technical ease to perform the esp-l block

  48 hours postoperative

• Patient satisfaction survey on pain management

  48 hours postoperative

• Describe de side effects of the lumbar ESP block and morphine

  48 hours postoperative

Study Arms (2)

ESP-L

EXPERIMENTAL

After hip fracture surgery ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%

Drug: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%

No ESP-L

NO INTERVENTION

Conventional intravenous analgesia after hip fracture surgery

Interventions

Lumbar Erector Spinae Plane Block. L bupivacaína 0.25% DRUG

Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%

ESP-L

Eligibility Criteria

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

You may qualify if:

• Both sexes over 18 years of age having undergone hip surgery
• ASA I-III (classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk)
• Capacity to comprehend the principles of pain assessment using the VAS visual analogue scale
• Previously signed an informed consent.

You may not qualify if:

• Contraindications for the technique and/or the drugs used in this context
• Technical inability to perform the block
• Severe cognitive impairment or prior mental disabilities described in their medical records
• Patients already included in other clinical trials.

Sponsors & Collaborators

• Hospital Álvaro Cunqueiro: lead

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Related Publications (1)

• Garcia-Reza L, Raposeiras S, P Loureiro J, Pita-Romero R, Amate Pena JJ, Pereira Loureiro MA. Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854.

  PMID: 40953436 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura García Reza

  Hospital Álvaro Cunqueiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura García Reza

CONTACT

626708239; laura.garcia.reza@sergas.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Pragmatic randomized low interventional single-centre parallel non blinded design with blinded assessment of the objectives.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic single-centre parallel group randomized clinical trial

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 22, 2024
• Study Start: June 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)