Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT06155903
Status:
COMPLETED
Last Update Posted:
2025-05-04
First Post:
2023-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture
Sponsor:
Federico II University
Organization:
Study Overview
Official Title:
Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: