Analgesia for Clavicular Fracture and Surgery | NCT03933228

Studies
Analgesia for Clavicular Fracture and Surgery

NCT03933228

Sponsor

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Status

Completed

Last Update Posted

Apr 9, 2024Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Clavicular Fractures

Interventions

Interscalene-Cervical Plexus Block
Supraclavicular-Cervical Plexus Block

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Apr 28, 2019

First Submission Date that Met QC Criteria

Apr 28, 2019

First Posted Date

May 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.

Detailed Description

The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interscalene-Cervical Plexus Block		Ultrasound-Guided Combined Interscalene-Cervical Plexus Block	Procedure: Interscalene-Cervical Plexus Block
Supraclavicular-Cervical Plexus Block		Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block	Procedure: Supraclavicular-Cervical Plexus Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interscalene-Cervical Plexus Block	Procedure	Ultrasound-Guided Combined Interscalene-Cervical Plexus Block	Interscalene-Cervical Plexus Block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Block success rate	Sensory blockade was assessed using the pinprick test at the surgery site	At time 15 minutes after the block

Secondary Outcomes

Measure	Description	Time Frame
Acute complications	Number of participants with phrenic nerve palsy	At the end of surgery immediately

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block
Urgent or planned surgery

Exclusion Criteria:

Refused to sign informed consent
Pregnant women
Allergic to the local anesthetic

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

150

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruizhao Lv, M.D	Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine		Cangzhou	Hebei	061001	China