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NCT Number: NCT07104097

Comparison Between 2 Techniques for Lumbar-ESPB

Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate.

The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block.

Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia.

The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.

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Key information

Conditions

Hip Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primary total hip replacement
  • informed consent

Exclusion criteria

  • allergies to study drugs
  • spinal anesthesia contraindicated
  • kidney failure (GFR<30)
  • epilepsy, psychiatric disease, neurologic deficits
  • revision surgery
  • neuropathies in the lumbar area (tingling, hypoestesia, numbness, motor deficit)
  • no informed consent
  • pregnancy
  • alcohol/opioid abuse
  • emergency surgery/intensive care

Treatment and study plan

Spinal anesthesia

Procedure

spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml

superficial erector spinal plane block (ESPB)

Procedure

Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle

deep (inter laminar) erector spinal plane block (ESPB)

Procedure

Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 between L3 and L4 transverse process, between erector spinae muscle and deep muscles

Dexamethasone

Drug

8 mg iv preoperatively

Ibuprofen 400 mg

Drug

preoperatively and postoperatively (every 8 hours)

Paracetamol

Drug

1000 mg preoperatively and postoperatively (every 8 hours)

Morphine

Drug

Patient Controlled Analgesia

Primary outcomes

  1. sensory block

    Time frame: 24 hours

    incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh)

Secondary outcomes

  1. motor block

    Time frame: 24 hours

    block of extension and/or adduction of the thigh

  2. postoperative pain

    Time frame: 48 hours

    numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

  3. morphine consumption

    Time frame: 24 hours

    milligrams of morphine by patient controlled analgesia intravenously

  4. quality of recovery

    Time frame: 48 hours

    QoR-15 (Quality of Recovery 15 items) questionnaire - global measure of postoperative recovery, with a score ranging from 0 (extremely poor) to 150 (excellent)

  5. complications

    Time frame: 48 hours

    presence of nausea and vomiting, any other complication

  6. discharge ability

    Time frame: 48 hours

    PADDs score (Post Anaesthetic Discharge Scoring System) - 5 items, each scored from 0 to 2, where the higher the score (from 0 to 10), the greater the degree of the patient's recovery and readiness to be discharged. Scores of 9 or 10 mean the patient can be safely discharged.

Study contacts

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

Dario Bugada

CONTACT

[email protected]

+393405230454

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block

Acronym: ESPTA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
May 12, 2026

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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