Comparison Between 2 Techniques for Lumbar-ESPB (ESPTA)

Papa Giovanni XXIII Hospital

Status: Not yet enrolling

Conditions: Hip Surgery

Treatments: Procedure: superficial erector spinal plane block (ESPB); Drug: Morphine; Drug: Paracetamol; Procedure: spinal anesthesia; Drug: Ibuprofen 400 mg; Drug: Dexamethasone; Procedure: deep (inter laminar) erector spinal plane block (ESPB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07104097

0018028/25

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

superficial ESPB

Active Comparator group

Description:

Injection on top of L3 transverse process, plane between bone and erector spinae muscle

Treatment:

Drug: Ibuprofen 400 mg

Drug: Dexamethasone

Procedure: spinal anesthesia

Drug: Morphine

Drug: Paracetamol

Procedure: superficial erector spinal plane block (ESPB)

deep ESPB

Experimental group

Description:

Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles

Treatment:

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

Drug: Ibuprofen 400 mg

Drug: Dexamethasone

Procedure: spinal anesthesia

Drug: Morphine

Drug: Paracetamol