Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture

Federico II University

Status: Completed

Conditions: Spinal Anesthesia; Peripheral Nerve Block; Femur Fracture

Treatments: Drug: Anesthesiological mixtures (Peripheral nerve block); Procedure: Peripheral nerve blocks; Drug: Anesthesiological mixtures (Spinal anesthesia); Procedure: Selective Spinal Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06155903

2-2023-533

Details and patient eligibility

About

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.

Full 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)

Enrollment: 78 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

78 participants in 2 patient groups

Selective Spinal Anesthesia

Active Comparator group

Description:

The participant will receive selective spinal anesthesia.

Treatment:

Procedure: Selective Spinal Anesthesia

Drug: Anesthesiological mixtures (Spinal anesthesia)

Peripheral nerve blocks

Active Comparator group

Description:

The participant will receive a combination of femoral nerve block, sciatic nerve block with parasacral approach, lateral femoral cutaneous nerve block and obturator nerve block.

Treatment:

Procedure: Peripheral nerve blocks

Drug: Anesthesiological mixtures (Peripheral nerve block)