Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06567522

Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery

Led by Hospital Álvaro Cunqueiro · Updated on 2024-08-22

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Hip surgery is common, especially among elderly patients with multiple health conditions, where managing pain effectively can be challenging due to concerns about side effects and drug interactions. Researchers are evaluating whether the lumbar erector spinae plane block (L-ESP block), an ultrasound-guided regional anesthesia technique, can reduce opioid use and improve pain relief after hip and proximal femur surgeries. Participants will be randomly assigned to receive either the L-ESP block with 30 mL of levobupivacaine 0.25% at the L3-14 level after hip fracture surgery or conventional intravenous pain treatment without the block. The study compares pain reduction and opioid needs following surgery between these two groups. During the study, participants’ pain levels will be measured using the VAS scale within the first two hours after surgery. Researchers will also monitor opioid consumption, technical ease of performing the block, patient satisfaction with pain management, and side effects related to the block and morphine up to 48 hours postoperatively. The trial begins in June 2024 and continues through December 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older who have undergone hip surgery
  • Both sexes are eligible
  • Classified as ASA physical status I to III
  • Able to understand the pain assessment using the VAS scale
  • Previously signed informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to the regional anesthesia technique or drugs used
  • Technical inability to perform the lumbar ESP block
  • Severe cognitive impairment or prior mental disabilities documented
  • Currently enrolled in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 48 hours post surgery

Participants undergo hip surgery followed by either a lumbar erector spinae plane block with levobupivacaine or conventional intravenous analgesia.

1 surgery day visit and follow-up assessments within 48 hours

Trial Site Locations

Total: 1 location

1

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain, 36312

Actively Recruiting

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Research Team

L

Laura García Reza

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial.

Laura García-Reza, Sergio Raposeiras, Javier P Loureiro...

https://pubmed.ncbi.nlm.nih.gov/40953436