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

Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block (L-ESPB) Versus Absence of Locoregional Block in Hip Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Lumbar Erector Spinae Plane Block
• Intervention / Treatment: Drug: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Laura García Reza; Phone Number: 626708239; Email: laura.garcia.reza@sergas.es

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Recruiting
      • Hospital Alvaro Cunqueiro
      • Contact: Laura García Reza; Phone Number: 626708239; Email: laura.garcia.reza@sergas.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP-L; 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%; Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%
No Intervention: No ESP-L; Conventional intravenous analgesia after hip fracture surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Consumption of morphine (mg)	12 hours postoperative
Percentage of patients with technical ease to perform the esp-l block	We will define the technical ease of the esp-l block from 1 to 3. 1 being good and when we are able to clearly distinguish anatomical structures in order to carry out the locoregional analgesia, 2 would be equivalent to regular, when these are sensed but not clearly defined structures and bad when we are not able to distinguish any anatomical structure that allows us to carry out the block.	48 hours postoperative
Patient satisfaction survey on pain management	We will classify patients into two groups according to their satisfaction with pain management in the postoperative period of hip surgery. Being the group of patients who consider themselves satisfied with pain management when it meets their expectations and dissatisfied if the patients are discomforted with it.	48 hours postoperative
Describe de side effects of the lumbar ESP block and morphine	pruritus, nausea, vomiting, erythema, hypotension	48 hours postoperative

Collaborators and Investigators

• Sponsor: Hospital Álvaro Cunqueiro
• Investigators: Principal Investigator: Laura García Reza, Hospital Alvaro Cunqueiro

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 10, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ESPL - MORFINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes