Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

Complication of Anesthesia Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682300
• Other study ID #: 22-EO069
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Hospital del Río Hortega
• Contact: María Teresa F Fernandez Martín, MD
• Phone: 637571685
• Email: maitefm70[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1390
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: 18-65 years
• ASA I- IV
• Being scheduled for surgery with peripheral and/or fascial nerve blocks as the basis of anesthesia or as part of a multimodal analgesic strategy.

Exclusion Criteria:

• Refusal of the patient to participate in the study
• Contraindication for performing the regional technique (People with infections in the area of the skin where the puncture must be performed, allergy to anesthetics, severe blood coagulation disorders, previous nerve damage).
• Motor or sensory deficit prior to surgery in the metameric area susceptible to performing the block.

Related Conditions & MeSH terms

• Complication of Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Spain	Judith Andres	Valladolid	Castilla Y León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of complications of peripheral nerve blocks	The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain	2 years
Secondary	Etiology	Explain the etiology and mechanisms that contribute to nerve damage secondary to peripheral nerve blocks.	2 years
Secondary	Number of Factors related	Explain the factors related to complications associated with fascial blocks.	2 years