Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- sensory block
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
outcome assessor will not be aware of the technique used in the OR
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
Intervention: spinal anesthesia (Procedure)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
Intervention: Ibuprofen 400 mg (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
Intervention: Dexamethasone (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
Intervention: Ibuprofen 400 mg (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
Intervention: Paracetamol (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
Intervention: Morphine (Drug)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
Intervention: deep (inter laminar) erector spinal plane block (ESPB) (Procedure)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
Intervention: Dexamethasone (Drug)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
Intervention: Paracetamol (Drug)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
Intervention: Morphine (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
Intervention: spinal anesthesia (Procedure)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
Intervention: superficial erector spinal plane block (ESPB) (Procedure)
Outcomes
Primary Outcomes
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
- motor block(24 hours)
- postoperative pain(48 hours)
- morphine consumption(24 hours)
- quality of recovery(48 hours)
- complications(48 hours)
- discharge ability(48 hours)
- motor block(24 hours)
- postoperative pain(48 hours)
- morphine consumption(24 hours)
- quality of recovery(48 hours)
- complications(48 hours)
- discharge ability(48 hours)
Investigators
Dario Bugada
MD
Papa Giovanni XXIII Hospital