Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460792
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-04
Brief Title:
Ultrasound-guided Peripheral Nerve Blocks - a Database
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
The Quality of Ultrasound-guided Peripheral Nerve Blocks Nerve Injury Bleeding Complications and Learning - a Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Blockbase
Brief Summary:
Peripheral nerve blocks are often used in anaesthesia They can be used as the only method of anaesthesia during surgery or in combination with other methods eg general anaesthesia and sedation Moreover peripheral nerve blocks are used to treat postoperative pain alleviate pain in trauma patients and for painful procedures
For a method to be clinically useful it is essential to understand the factors contributing to high success rates It is equally important to know the complications related to the method Finally it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance Therefore we aim to establish a prospective and ongoing database to gain insight into 1 Factors contributing to block quality eg success rate and nerve block duration 2 Frequencies and types of nerve injuries and bleeding complications associated with the block procedure 3 Tracking of block performance by anaesthesiologists
For a method to be clinically useful it is essential to understand the factors contributing to high success rates It is equally important to know the complications related to the method Finally it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance Therefore we aim to establish a prospective and ongoing database to gain insight into 1 Factors contributing to block quality eg success rate and nerve block duration 2 Frequencies and types of nerve injuries and bleeding complications associated with the block procedure 3 Tracking of block performance by anaesthesiologists
Detailed Description:
Introduction Peripheral nerve blocks are often used in anaesthesia They can be used as the only method of anaesthesia during surgery or in combination with other methods eg general anaesthesia and sedation Moreover peripheral nerve blocks are used to treat postoperative pain alleviate pain in trauma patients and for painful procedures
For a method to be clinically useful it is essential to understand the factors contributing to high success rates It is equally important to know the complications related to the method Finally it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance Therefore we aim to establish a prospective and ongoing database to gain insight into 1 Factors contributing to block quality eg success rate and nerve block duration 2 Frequencies and types of nerve injuries and bleeding complications associated with the block procedure 3 Tracking of block performance by anaesthesiologists These three points are described in more detail below
1 Success rate block quality It is difficult to get an overview of the success rates of peripheral nerve blocks Most studies focus on one specific nerve block and the number of included patients is often low In addition the block procedure is performed by a few anaesthesiologists who are highly skilled in the specific procedure By establishing a database including the most used peripheral nerve blocks used in different settings ie surgery perioperative pain management and painful procedures and by including anaesthesiologists with varying levels of experience and expertise it will be possible to get a more detailed picture of factors that are important for achieving high success rates
2 Complications Nerve injury Peripheral nerve blocks are generally considered safe to use with low complication rates However complications can be severe and result in permanent nerve injury Therefore it is essential to get an overview of block-related complications and factors associated with these complications Different regions have specific characteristics and complications probably follow a characteristic pattern A database with sufficient data will allow us to detail essential factors for understanding how complications develop and turn into permanent injuries
Bleeding Today many patients receive anticoagulant therapy We will therefore collect data on bleeding complications associated with the block procedure
3 Learning Ultrasound-guided peripheral nerve blocks require a certain amount of skill to deposit LA in the correct place By gathering data on block quality from individual anaesthesiologists over time it will be possible to gain insight into learning curves and factors important for learning different block procedures
Methods Study design Observational prospective cohort study Setting Initially a single-centre study at the Department of Anaesthesiology North Zealand Hospital We envision to include as many centres as possible in Denmark
Participants Patients scheduled for peripheral nerve blocks Prior to collecting follow-up data informed consent will be obtained from each participant through an automated and secure sms system
Variables The following variables are registered
Patient demographics Social security number age sex height weight comorbidity diabetes use of insulin chronic pain pain medication anticoagulant medication ASA status and type of surgery performed
Technical block data Date and time for the peripheral nerve block performing anaesthesiologist block details name of block type of LA volume of LA concentration of LA anatomical location of LA injection adjuvants used onset time
Peripheral nerve block quality and success rate success rate need of supplementary blocks use of tourniquet reasons for block deemed unsuccessful
Bleeding complications details on bleeding complications associated with the block procedure
Follow-up by surveys
Day 1 duration of peripheral nerve block pain after block termination Day 2 measures if block duration 24 h Day 30 signs of nerve injury altered sensation pain decreased muscle force Day 90 continuous signs of nerve injury altered sensation pain decreased muscle force
Day 365 continuous signs of nerve injury altered sensation pain decreased muscle force
Data sourcesmeasurements All variables are part of data that are normally registered for patients who have a peripheral nerve block However the purpose of establishing the database is to perform a systematic data capture We will use the secure web application for online research databases REDCap to enter data through electronic CRFs and through surveys sent to the patients follow-up
Study size The purpose of establishing the database is to continuously register peripheral nerve blocks in patients As such there is no pre-defined study size
Statistical methods We will use descriptive statistics and inferential statistical analyses eg regression analyses etc
For a method to be clinically useful it is essential to understand the factors contributing to high success rates It is equally important to know the complications related to the method Finally it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance Therefore we aim to establish a prospective and ongoing database to gain insight into 1 Factors contributing to block quality eg success rate and nerve block duration 2 Frequencies and types of nerve injuries and bleeding complications associated with the block procedure 3 Tracking of block performance by anaesthesiologists These three points are described in more detail below
1 Success rate block quality It is difficult to get an overview of the success rates of peripheral nerve blocks Most studies focus on one specific nerve block and the number of included patients is often low In addition the block procedure is performed by a few anaesthesiologists who are highly skilled in the specific procedure By establishing a database including the most used peripheral nerve blocks used in different settings ie surgery perioperative pain management and painful procedures and by including anaesthesiologists with varying levels of experience and expertise it will be possible to get a more detailed picture of factors that are important for achieving high success rates
2 Complications Nerve injury Peripheral nerve blocks are generally considered safe to use with low complication rates However complications can be severe and result in permanent nerve injury Therefore it is essential to get an overview of block-related complications and factors associated with these complications Different regions have specific characteristics and complications probably follow a characteristic pattern A database with sufficient data will allow us to detail essential factors for understanding how complications develop and turn into permanent injuries
Bleeding Today many patients receive anticoagulant therapy We will therefore collect data on bleeding complications associated with the block procedure
3 Learning Ultrasound-guided peripheral nerve blocks require a certain amount of skill to deposit LA in the correct place By gathering data on block quality from individual anaesthesiologists over time it will be possible to gain insight into learning curves and factors important for learning different block procedures
Methods Study design Observational prospective cohort study Setting Initially a single-centre study at the Department of Anaesthesiology North Zealand Hospital We envision to include as many centres as possible in Denmark
Participants Patients scheduled for peripheral nerve blocks Prior to collecting follow-up data informed consent will be obtained from each participant through an automated and secure sms system
Variables The following variables are registered
Patient demographics Social security number age sex height weight comorbidity diabetes use of insulin chronic pain pain medication anticoagulant medication ASA status and type of surgery performed
Technical block data Date and time for the peripheral nerve block performing anaesthesiologist block details name of block type of LA volume of LA concentration of LA anatomical location of LA injection adjuvants used onset time
Peripheral nerve block quality and success rate success rate need of supplementary blocks use of tourniquet reasons for block deemed unsuccessful
Bleeding complications details on bleeding complications associated with the block procedure
Follow-up by surveys
Day 1 duration of peripheral nerve block pain after block termination Day 2 measures if block duration 24 h Day 30 signs of nerve injury altered sensation pain decreased muscle force Day 90 continuous signs of nerve injury altered sensation pain decreased muscle force
Day 365 continuous signs of nerve injury altered sensation pain decreased muscle force
Data sourcesmeasurements All variables are part of data that are normally registered for patients who have a peripheral nerve block However the purpose of establishing the database is to perform a systematic data capture We will use the secure web application for online research databases REDCap to enter data through electronic CRFs and through surveys sent to the patients follow-up
Study size The purpose of establishing the database is to continuously register peripheral nerve blocks in patients As such there is no pre-defined study size
Statistical methods We will use descriptive statistics and inferential statistical analyses eg regression analyses etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None