Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture

Spinal Anesthesia Clinical Trial

Official title: Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study

Status Completed

Clinical Trial Summary

Femur Fractures (PF) are nowadays one of the main social and health problems in industrialized countries. PF are defined as crack or break of the proximal femur and they represent an important cause of morbidity and mortality in elderly population.

The main prospective and retrospective studies do not show the superiority of subarachnoid anesthesia over general anesthesia in terms of 30-day mortality and post-operative complications, however they always recommend the execution of PeripheralNerve Blocks (PNB). Loco-regional anesthesia plays a fundamental role in the treatment of peri-operative pain assuring better hemodynamic stability and has already fully entered national and international pain management protocols, because it allows faster recovery times with a reduction in the use of intravenous analgesic drugs in particular opioids and consequently a faster discharge and a reduction in peri-operative complications and the costs of assistance.

The aim of our study will be to propose an anesthetic approach based on PNB that could be particularly suitable for frail patients especially when Neuroaxial Anesthesia (NA) is not feasible due to difficulty to position the patient or to the withdrawal time of anticoagulant or antiplatelet therapies.

Clinical Trial 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. A co-loading with 500 ml of intravenous crystalloids will be done and ondansetron 4 mg will be administered intravenously; pre-procedural sedation will be performed with Midazolam 0.01-0.03 mg/Kg. All patients in both groups will receive intraoperative sedation with Dexmedetomidine 0.4-0.7 gamma/Kg/h and o2-therapy with a nasal cannula with a flow rate of 2L/min. At this point, the type of anesthesia will be followed on the basis of the randomization group.The following variables will be evaluated:

• Postoperative pain evaluated by VAS and PAINAD scales

• time to motor block regression (duration of motor block)

• rate of side effects (nausea, vomiting and delirum)

• rescue dose analgesics needed (interval between anesthesia and first rescue dose)

• surgical compliance (obtained with a 5-point Likert scale score filled out by the surgeon)

• duration of surgery ;

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Peripheral Nerve Block
• Spinal Anesthesia

• NCT number: NCT06155903
• Study type: Interventional
• Source: Federico II University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Completion date: June 15, 2024