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NCT Number: NCT06567522

Comparative Assessment of Effectiveness and Safety of 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.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Lumbar Erector Spinae Plane Block Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location status: Recruiting

Location contact

Laura García Reza

CONTACT

[email protected]

626708239

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%

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.

    Time frame: 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 outcomes

  1. 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

    Time frame: 12 hours postoperative

    Consumption of morphine (mg)

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

    Time frame: 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.

  3. Patient satisfaction survey on pain management

    Time frame: 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.

  4. Describe de side effects of the lumbar ESP block and morphine

    Time frame: 48 hours postoperative

    pruritus, nausea, vomiting, erythema, hypotension

Study contacts

Contact information is provided by the study sponsor or research team.

Laura García Reza

CONTACT

[email protected]

626708239

Sponsors and collaborators

Lead sponsor

Hospital Álvaro Cunqueiro

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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