Clinical trial NCT06155903: Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture
Official title: Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Peripheral Nerve Block
Spinal Anesthesia
Keywords: SPINAL ANESTHESIA
FEMUR FRACTURE
NERVE BLOCK
LOCOREGIONAL ANESTHESIA
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proximal Femur Fractures (PFF) represent one of the most common orthopedic injuries worldwide, affecting especially elderly patients with potentially disabling outcomes and a marked impairment of quality of life. Taking into account their inherent instability, PFF are usually treated surgically within the shortest possible delay in order to reduce the risk of major and minor complications, the length of hospitalization and related costs. In this setting, most retrospective and prospective studies have reported a similar 30-day mortality rate comparing Spinal Anesthesia (SA) and General Anesthesia (GA), often recommending an adjuvant Peripheral Nerve Block (PNBs) to control postoperative pain. There is consensus that anticoagulant therapy, lack of pharmacological optimization or other conditions may represent a contraindication to SA. In these cases, blocking the nerves responsible for innervation of the proximal femur (i.e., the femoral, lateral femoral-cutaneous, obturators and sciatic nerves) may be a useful option. This study will aim to compare the incidence of intraoperative and postoperative adverse events, as well as the analgesic efficacy of the PNBs compared to SSA in patients diagnosed with PFF who underwent intramedullary nailing as a method of fixation.

Detailed description: A venous access (16-18 G) will be placed in the operating room and antibiotic prophylaxis will be administered (Cefazolin 1 or 2 gr. iv or, in case of allergy, Clindamycin 600 mg iv). Pantoprazole 40 mg iv will also be administered. Pulse oximetry (SpO2), heart rate (HR), body temperature (C°), continuous invasive blood pressure (cIBP), brain oximetry with ForeSight will be monitored. Risk factors of Postoperative Nausea and Vomiting (PONV) will be assessed using the Apfel score. Antiemetic prophylaxis will be administered in accordance with the 2020 Fourth Consensus Guidelines for the Management of PONV. A pre-loading will be started with 500 ml of crystalloids iv will be administered; pre-procedural sedation will be performed with Midazolam 0.03 mg/Kg until a Richmond Agitation Sedation Scale (RASS) -1 or -2 will be obtained. All patients will receive intraoperative sedation with Dexmedetomidine 0.7 gamma/Kg/h and o2-therapy with a nasal cannula with a flow rate of 2L/min. We will also proceed to an intraoperative fluid administration of 15-20 ml / kg / hour of iv crystalloids. Rate of hypotension and bradycardia will be monitored during surgery. At this point, the type of anesthesia will be followed based on the randomization group.The following variables will be evaluated:

* intraoperative haemodynamic adverse events (rates of hypotension and bradycardia)
* postoperative adverse events (rates of nausea/vomiting and delirium and rate of deep vein thrombosis, myocardial infarction and neurological lesion during the hospital stay);
* postoperative pain evaluated by NRS and PAINED
* time to mobilization
* need of analgesic rescue dose after surgery
* lenght of stay
* bromage and hollmen scale of healthy limb and fractured limb assessed at different time
* surgical satisfaction (evaluated with 6-point Likert scale).
* the duration of surgery (min)

Eligibility criteria: "Inclusion Criteria" :

* Subject has signed and dated an Informed Consent Form
* Subject is classified as a ASA (American Society of Anesthesiologists) status I-IV
* Subject is age over 65 years old
* Subjects with femur fracture, candidates for intramedullary nailing surgery, to be operated on within 48 hours

"Exclusion Criteria":

* Age younger than 65 years
* Subject with contraindications to subarachnoid technique or peripherical nerve blocks
* Subject with local anesthetic allergy
* Subject in whom the treatment protocol could not be fully applied were excluded from this study.
* Study refusal
* Neurological disease of the lower limbs

Primary outcomes:
measure: Postoperative pain evaluated by NRS scales
timeFrame: Every 6 hours during treatment until the first 24 postoperative hours
measure: Postoperative pain evaluated by PAINAD scales
timeFrame: Every 6 hours during treatment until the first 24 postoperative hours
measure: Rate of postoperative nausea and vomiting (PONV)
timeFrame: Every 6 hours during treatment until the first 24 postoperative hours
measure: Rate of Delirium
timeFrame: Every 6 hours during treatment until the first 24 postoperative hours
measure: Rate of deep vein thrombosis
timeFrame: up to 1 weeks
measure: Rate of myocardial infarction
timeFrame: up to 1 weeks
measure: Rate of neurological lesion
timeFrame: up to 1 weeks
measure: Intraoperative haemodynamic adverse events
timeFrame: From the beginning to the end of surgery
Secondary outcomes:
measure: Need of analgesic rescue dose
timeFrame: From the end of treatment to 24 hours postoperatively
measure: Time to mobilization (hours)
timeFrame: Time to mobilization will be assessed immediately after the locoregional procedure, up to 24 hours postoperatively.
measure: Lenght of stay (days)
timeFrame: from date of hospital admission up to 1 weeks
measure: Bromage and Hollmen scale of healthy limb and fractured limb assessed at different time
timeFrame: Motor block and sensory block were assessed before LA injection (baseline time) and 10 , 15 and 20 minutes after baseline time and every 30 minute during the surgery
Other outcomes:
measure: The duration of surgery (min)
timeFrame: From the beginning of surgery up to 120 minutes
measure: Surgical satisfaction related to anesthesiological plane
timeFrame: 1 hours after surgery
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Antonio Coviello, Researcher
role: PRINCIPAL_INVESTIGATOR
References: