Comparison Between 2 Techniques for Lumbar-ESPB

Not Applicable

Not yet recruiting

• Conditions: Hip Surgery
• Interventions: Procedure: spinal anesthesia; Procedure: superficial erector spinal plane block (ESPB); Procedure: deep (inter laminar) erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine

• Registration Number: NCT07104097
• Lead Sponsor: Papa Giovanni XXIII Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Status Verified: 2025-08
• Study First Posted: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study Start: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-06-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
superficial ESPB	spinal anesthesia	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
superficial ESPB	superficial erector spinal plane block (ESPB)	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
superficial ESPB	Dexamethasone	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
superficial ESPB	Ibuprofen 400 mg	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
superficial ESPB	Paracetamol	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
superficial ESPB	Morphine	Injection on top of L3 transverse process, plane between bone and erector spinae muscle
deep ESPB	spinal anesthesia	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
deep ESPB	deep (inter laminar) erector spinal plane block (ESPB)	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
deep ESPB	Dexamethasone	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
deep ESPB	Ibuprofen 400 mg	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
deep ESPB	Paracetamol	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
deep ESPB	Morphine	Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aast Papa Giovanni Xxiii; 🇮🇹 Bergamo, Italy