NCT05682300

Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

"Incidence and Etiology of Complications Associated With Regional Anesthesia of Peripheral Nerves: a Prospective Study"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,390 (actual)
• Sponsor: Hospital del Rio Hortega · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Procedures performed under regional anesthesia, especially peripheral nerve blocks (PNB) have increased markedly in recent decades. However, like any technical procedure, these techniques carry an implicit risk of complications. The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain.

Detailed description

Introduction. The number of procedures performed under regional anesthesia, especially peripheral nerve blocks (BNP) have increased notably in recent decades due to the improvement in pain control and the quality of post-anesthetic recovery that they provide. However, like any technical procedure, these techniques carry an implicit risk of complications. Purpose. The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain. Material and methods. The postoperative results regarding the complications of regional anesthesia of peripheral nerves will be evaluated in a national audit of a prospective observational cohort in which hospitals at the state level in which these regional techniques are routinely performed will participate. A minimum sample size has been calculated on a population of 100,000 patients and a 95% confidence interval of 1,390, assuming a complication rate of 0.2% based on previous publications. Inclusion criteria correspond to patients older than 18 years scheduled for surgery with a peripheral regional anesthesia technique as the basis of anesthesia or as part of a multimodal analgesic strategy.

Conditions

• Complication of Anesthesia

Interventions

Type	Name	Description
PROCEDURE	peripheral nerve block	After signing the informed consent by the patient, specific for this observational study, the peripheral regional anesthesia technique will be performed following the usual practice of the anesthesiologist responsible for the surgery. Under standard monitoring and taking into account the necessary aseptic measures, either peripheral nerve blocks (for surgeries involving extremities) or fascial blocks (for surgeries involving the chest wall, abdomen, or spine) will be performed.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-01-12
• Last updated: 2025-03-14

Locations

1 site across 1 country: Spain