Hip Surgery
Conditions
Keywords
erector spinae plane block, hip surgery, sensory block, motor block, local anesthetic
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.
Interventions
PROCEDUREspinal anesthesia
spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml
PROCEDUREsuperficial erector spinal plane block (ESPB)
Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle
PROCEDUREdeep (inter laminar) erector spinal plane block (ESPB)
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
DRUGDexamethasone
8 mg iv preoperatively
DRUGIbuprofen 400 mg
preoperatively and postoperatively (every 8 hours)
DRUGParacetamol
1000 mg preoperatively and postoperatively (every 8 hours)
DRUGMorphine
Patient Controlled Analgesia
Sponsors
Papa Giovanni XXIII Hospital
Study design
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
Intervention model description
randomized trial, single blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Italy
Outcome results
None listed