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

Phase 4

Recruiting

• Conditions: Hip Fractures; Lumbar Erector Spinae Plane Block
• Interventions: Drug: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%

• Registration Number: NCT06567522
• Lead Sponsor: Hospital Álvaro Cunqueiro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-08
• Status Verified: 2024-08
• Study First Submitted: 2024-08-10
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP-L	Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%	After hip fracture surgery ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%

Primary Outcome Measures

Name	Time	Method
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.	2 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.

Secondary Outcome Measures

Name	Time	Method
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	Consumption of morphine (mg)
Percentage of patients with technical ease to perform the esp-l block	48 hours postoperative	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.
Patient satisfaction survey on pain management	48 hours postoperative	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.
Describe de side effects of the lumbar ESP block and morphine	48 hours postoperative	pruritus, nausea, vomiting, erythema, hypotension

Trial Locations

Locations (1)

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain