Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks (CARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complication of Anesthesia
• Intervention / Treatment: Procedure: peripheral nerve block

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.

• Study Type: Observational
• Enrollment (Estimated): 1390

Contacts and Locations

• Study Contact: Name: María Teresa F Fernandez Martín, MD; Phone Number: 637571685; Email: maitefm70@hotmail.com
• Study Contact Backup: Name: Cesar Aldecoa

Study Locations

• Spain
  • Castilla Y León
    • Valladolid, Castilla Y León, Spain, 47008
      • Recruiting
      • Judith Andres
      • Contact: María Teresa F Martín; Phone Number: 637571685

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out in all those hospitals nationwide that agree to be part of it.

Each participating center will recruit patients for one year or until the estimated sample size is achieved.

After signing the informed consent by the patient, specific to 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient under regional anesthesia; patients who recieve peripheral nerve blocks as analgesic technique

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiology	Explain the etiology and mechanisms that contribute to nerve damage secondary to peripheral nerve blocks.	2 years
Number of Factors related	Explain the factors related to complications associated with fascial blocks.	2 years

Collaborators and Investigators

• Sponsor: Hospital del Río Hortega
• Investigators: Study Chair: María T Fernandez, Hospital del Rio Hortega

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: regional anesthesia; complication; peripheral nerve
• Other Study ID Numbers: 22-EO069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

The study will be carried out in all those hospitals nationwide that agree to be part of it.

Each participating center will recruit patients for one year or until the estimated sample size is achieved.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No