drugset / Trial / NCT06155903

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

NCT06155903

Completed 78 enrolled Federico II University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-12-31
Primary completion
2024-04-01
Completion
2024-06-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 7.5 mg Intrathecal
Comparator Dexamethasone Small molecule 4 mg Other
Comparator Mepivacaine Other / unclassified 100 mg Other
Comparator Ropivacaine Other / unclassified 37.5 mg Other
Comparator Sufentanil Other / unclassified 5 ug Intrathecal

Indications

No indication recorded.