Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04685291
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2020-12-14
Brief Title:
Ultrasound-guided Block of the Supraclavicular Nerves in Clavicular Fractures
Sponsor:
Eckehart SCHÖLL
Organization:
Merian Iselin Klinik
Study Overview
Official Title:
Ultrasound-guided Block of the Supraclavicular Nerves for Clavicular Fractures in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2023-07
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:
US-SCNB_Clav
Brief Summary:
A Clavicular fractures CF is uncomfortable for the affected patients because the fragments are often strongly displaced by the muscles attached to them and the bony fragments move painfully with every movement of the shoulder In emergency departments ED so far CF has been tackled with drugs that are taken by mouth or injected into a vein This type of pain management has many side effects since these painkillers act systemically
The aim of the study is to investigate the effectiveness of pain relief in CF to be operated using regional anaesthesia For this purpose the supraclavicular nerves SCN which run directly under the skin of the neck will be located using an ultrasound device US Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of local aesthetic LA are injected around the nerves The pain relief may last 12 up to 24 hours which bridges the time until the operation OP
In order to compare this procedure CF-patients will be divided into two groups of which the control group 21 will be treated with painkillers in the conventional manner and the intervention group 21 will receive the US-guided block of the SCN
With the small amount of LA injected adverse events AE are very rare Nevertheless the puncture in the side of the neck may cause bruises at the site of the injection or uncomfortable spreading pain Systemic side effects are unlikely
In the intervention group the investigators expect a nearly complete pain relief up to the operation than with conventional pain therapy and a lower rate of side effects than with systemic administration of painkillers
The aim of the study is to investigate the effectiveness of pain relief in CF to be operated using regional anaesthesia For this purpose the supraclavicular nerves SCN which run directly under the skin of the neck will be located using an ultrasound device US Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of local aesthetic LA are injected around the nerves The pain relief may last 12 up to 24 hours which bridges the time until the operation OP
In order to compare this procedure CF-patients will be divided into two groups of which the control group 21 will be treated with painkillers in the conventional manner and the intervention group 21 will receive the US-guided block of the SCN
With the small amount of LA injected adverse events AE are very rare Nevertheless the puncture in the side of the neck may cause bruises at the site of the injection or uncomfortable spreading pain Systemic side effects are unlikely
In the intervention group the investigators expect a nearly complete pain relief up to the operation than with conventional pain therapy and a lower rate of side effects than with systemic administration of painkillers
Detailed Description:
In 2013 Tran and colleagues reported about a controversial knowledge concerning the sensory innervation of the clavicle which may lead to different approaches of regional analgesia RA in CF superficial cervical plexus blocks interscalene blocks and combined superficial cervical plexus-interscalene blocks Since the innervation of the clavicle comes from four nerves supraclavicular nerves subclavian nerve long thoracic nerve and suprascapular nerve it seams to be quite difficult to guarantee a complete sensible clavicular block for an operation Nevertheless few case reports exist witch describe clavicle operations under RA alone However in these cases a considerable amount of local anaesthetics LA has been used that it may be assumed that there could have been dangerous side effects
Valdés-Vilches and Sánchez-del Águila pronounced the importance of the supraclavicular nerves SCN in CF For that reason our purpose is to determine the effectivity of a single nerve block of SCN in CF in the ED with only 2-3 millilitres of LA The aim of our study is to investigate the effectiveness of this method in CF to be operated up to 24 hours later For this purpose the SCN which run directly under the skin of the neck will be located using an ultrasound device US Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of LA are injected around the nerves The pain relief may last 12 up to 24 hours which bridges the time until the operation OP
In order to compare this new procedure CF-patients will be divided into two groups of which the control group 20 will be treated with painkillers in the conventional manner and the intervention group 20 will receive the US-guided block of the SCN
The following medical products and medicaments will be used which are all already registered and authorised in Switzerland
US-machines Samsung HS60 High-End with linear-probe array LA4-18BD Samsung RS85 Premium Radiology with linear probe LA4-18B
Needle PAJUNK SonoTAP 24 Gauge x 40mm
LA 3 ml Bupivacaine 05 75mcg Clonidine as an adjuvant The LA will be used in accordance with the prescribing information The dose will be up to 10 fold lower than the usual used dosages in cervical nerve blocks since with US-guidance there will be an excellent accuracy to approach the desired single nerve
In the intervention group the investigators expect a nearly complete pain relief up to the operation than with conventional pain management and a lower rate of side effects than with systemic administration of painkillers
With the small amount of LA injected adverse events AE are expected very rare Nevertheless the puncture in the side of the neck may cause bruises at the site of the injection or uncomfortable spreading pain Systemic side effects are unlikely A well-known and much feared AE of RA of the brachial and cervical plexus is accidental anaesthesia of the phrenic nerve which runs from the neck to the diaphragm near the four aforementioned nerves The paralysis of the phrenic nerve by the injected LA can cause breathing difficulties because the diaphragm is the main breathing muscle Another possible complication is a drop in blood pressure and heart rate which can result from anaesthesia of the autonomic nerves in the neck For these reasons RA of the brachial and cervical plexus should be performed with as little LA as possible However if the SCN-block is performed correctly the LA can neither reach the phrenic nerve nor the vegetative nerves since the SCN lays outside the prevertebral layer of the deep cervical fascia where the phrenic and the vegetative nerves lie within
Preliminary investigations in our ED in the last two years have shown that 2-3 millilitres of LA are too small a quantity of fluid to reach the phrenic nerve or to cause serious systemic side effects through absorption
Valdés-Vilches and Sánchez-del Águila pronounced the importance of the supraclavicular nerves SCN in CF For that reason our purpose is to determine the effectivity of a single nerve block of SCN in CF in the ED with only 2-3 millilitres of LA The aim of our study is to investigate the effectiveness of this method in CF to be operated up to 24 hours later For this purpose the SCN which run directly under the skin of the neck will be located using an ultrasound device US Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of LA are injected around the nerves The pain relief may last 12 up to 24 hours which bridges the time until the operation OP
In order to compare this new procedure CF-patients will be divided into two groups of which the control group 20 will be treated with painkillers in the conventional manner and the intervention group 20 will receive the US-guided block of the SCN
The following medical products and medicaments will be used which are all already registered and authorised in Switzerland
US-machines Samsung HS60 High-End with linear-probe array LA4-18BD Samsung RS85 Premium Radiology with linear probe LA4-18B
Needle PAJUNK SonoTAP 24 Gauge x 40mm
LA 3 ml Bupivacaine 05 75mcg Clonidine as an adjuvant The LA will be used in accordance with the prescribing information The dose will be up to 10 fold lower than the usual used dosages in cervical nerve blocks since with US-guidance there will be an excellent accuracy to approach the desired single nerve
In the intervention group the investigators expect a nearly complete pain relief up to the operation than with conventional pain management and a lower rate of side effects than with systemic administration of painkillers
With the small amount of LA injected adverse events AE are expected very rare Nevertheless the puncture in the side of the neck may cause bruises at the site of the injection or uncomfortable spreading pain Systemic side effects are unlikely A well-known and much feared AE of RA of the brachial and cervical plexus is accidental anaesthesia of the phrenic nerve which runs from the neck to the diaphragm near the four aforementioned nerves The paralysis of the phrenic nerve by the injected LA can cause breathing difficulties because the diaphragm is the main breathing muscle Another possible complication is a drop in blood pressure and heart rate which can result from anaesthesia of the autonomic nerves in the neck For these reasons RA of the brachial and cervical plexus should be performed with as little LA as possible However if the SCN-block is performed correctly the LA can neither reach the phrenic nerve nor the vegetative nerves since the SCN lays outside the prevertebral layer of the deep cervical fascia where the phrenic and the vegetative nerves lie within
Preliminary investigations in our ED in the last two years have shown that 2-3 millilitres of LA are too small a quantity of fluid to reach the phrenic nerve or to cause serious systemic side effects through absorption
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