Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752410
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2021-02-09
Brief Title:
Selective Trunk Block A Study to Evaluate Block Dynamics Effects and Efficacy for Upper Limb Surgery
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Selective Trunk Block A Prospective Non-Randomized Study to Evaluate Block Dynamics Effects on Ipsilateral Hemidiaphragmatic Phrenic Nerve Function and Efficacy for Upper Extremity Surgery
Status:
COMPLETED
Status Verified Date:
2021-07
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:
None
Brief Summary:
Brachial plexus block BPB is frequently used as the sole anesthetic technique for upper extremity surgery The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity However occasionally surgery entails that the whole upper extremity ie from the shoulder to the elbow or even the forearm wrist or hands This clinical challenge has been addressed previously using a combination of BPB techniques The investigator has recently demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle including the three trunks using ultrasound imaging Since majority of the innervation of the upper extremity ie shoulder arm elbow forearm wrist and hand originates from the three trunks of the brachial plexus the investigator hypothesized that selectively blocking upper middle and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity This study is a continuation of a previously approved study with title Selective Trunk Brachial Plexus Block A Prospective Non-Randomized Study of Intervention NCT04510259 after the amendment study title protocol and increased sample size was rejected by local IRB and suggested to submit as a new protocol The aim of this study is to assess a novel brachial plexus block technique the selective trunk block SeTB and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity
Detailed Description:
Brachial plexus block BPB is frequently used as the sole anesthetic technique for upper extremity surgery The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity shoulder to fingers However occasionally surgery entails that the whole upper extremity is anesthetized ie from the shoulder to the elbow or even the forearm wrist or hands This clinical challenge has been addressed previously using a combination of BPB hybrid techniques The investigator has recently demonstrated that it is feasible to accurately identify majority of the individual components of the brachial plexus above the clavicle including the three trunks using ultrasound imaging Since majority of the innervation of the upper extremity ie shoulder arm elbow forearm wrist and hand originates from or pass through the three trunks of the brachial plexus the investigator hypothesized that selectively blocking the upper middle and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity except for the area innervated by the intercostobrachial nerve T2 - medial aspect of the upper arm The investigator refers this novel technique as selective trunk block SeTB Currently there are no published data on block dynamics safety or efficacy of SeTB In addition there may be a potential advantage that phrenic nerve can be spared so this blockade will not affect the respiratory function as it is common to see phrenic nerve palsy after interscalene BPB 100 and supraclavicular BPB 50-67 This study is a continuation of a previously approved study with title Selective Trunk Brachial Plexus Block A Prospective Non-Randomized Study of Intervention NCT04510259 after the amendment study title protocol and increased sample size was rejected by local IRB and suggested to submit as a new protocol The aim of this study is to assess a novel brachial plexus block technique the selective trunk block SeTB and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity
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