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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| superficial ESPB | Active Comparator | Injection on top of L3 transverse process, plane between bone and erector spinae muscle |
|
| deep ESPB | Experimental | Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal anesthesia | Procedure | spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| sensory block | incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| motor block | block of extension and/or adduction of the thigh | 24 hours |
| postoperative pain | numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dario Bugada | Contact | +393405230454 | dariobugada@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aast Papa Giovanni Xxiii | Recruiting | Bergamo | 24127 | Italy |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D003907 | Dexamethasone |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D011246 | Pregnadienetriols |
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randomized trial, single blind
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outcome assessor will not be aware of the technique used in the OR
| 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 |
|
| 48 hours |
| morphine consumption | milligrams of morphine by patient controlled analgesia intravenously | 24 hours |
| quality of recovery | QoR-15 (Quality of Recovery 15 items) questionnaire - global measure of postoperative recovery, with a score ranging from 0 (extremely poor) to 150 (excellent) | 48 hours |
| complications | presence of nausea and vomiting, any other complication | 48 hours |
| discharge ability | 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. | 48 hours |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |