Comparison Between 2 Techniques for Lumbar-ESPB

NCT07104097 — Not applicable, Completed, 44 participants, Papa Giovanni XXIII Hospital

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

Registry	NCT07104097, acronym ESPTA
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	44 (Actual)
Sponsor	Papa Giovanni XXIII Hospital (Other)
Conditions	Hip Surgery
Interventions	spinal anesthesia, superficial erector spinal plane block (ESPB), deep (inter laminar) erector spinal plane block (ESPB), Dexamethasone, Ibuprofen 400 mg, Paracetamol, Morphine (Procedure, drug)
Dates	start 2025-10-06, primary completion 2026-06-30, completion 2026-07-02, first posted 2025-08-05, last updated 2026-08-25
Locations	1 site in Italy

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
superficial ESPB	Active comparator	Procedure: spinal anesthesia; Procedure: superficial erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
deep ESPB	Experimental	Procedure: spinal anesthesia; Procedure: deep (inter laminar) erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles

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

+Outcome measures

Primary outcomes

sensory block [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

motor block [24 hours]: block of extension and/or adduction of the thigh
postoperative pain [48 hours]: numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
morphine consumption [24 hours]: milligrams of morphine by patient controlled analgesia intravenously
quality of recovery [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)
complications [48 hours]: presence of nausea and vomiting, any other complication
discharge ability [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Aast Papa Giovanni Xxiii	Bergamo	Italy