Thoracic Paravertebral Blocks Using a Combination of Ropi... | NCT03677115

Studies
Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine

NCT03677115

Sponsor

China Medical University, China

Status

Withdrawn

Last Update Posted

Nov 12, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Thoracic Paravertebral Blocks

Interventions

Dexmedetomidine

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants enrolled

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Mar 30, 2023Estimated

Completion Date

Mar 30, 2023Estimated

First Submitted Date

Sep 16, 2018

First Submission Date that Met QC Criteria

Sep 18, 2018

First Posted Date

Sep 19, 2018Actual

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

Nov 5, 2021

Last Update Posted Date

Nov 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration.

Detailed Description

The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration. The effects of dexmedetomidine have only been compared at lower doses. This trial examined the effect of greater dose of dexmedetomidine on thoracic paravertebral block analgesia duration.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dexmedetomidine group	Experimental	a combination of ropivacaine and dexmedetomidine	Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	combination of ropivacaine and dexmedetomidine 20 ug every time	dexmedetomidine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of analgesia duration	Change of thoracic paravertebral block analgesia duration	Change from Baseline to 3 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were included in the study if they were ethnic Chinese,
American Society of Anesthesiologists (ASA) physical status I or II,
candidates for general anesthesia undergoing thoracic surgery

Exclusion Criteria:

Patients were excluded if they do not want to cooperate with the test,
had a history of radial artery puncture or coronary artery bypass grafting,
had acute vessel trauma,or had been diagnosed with Raynaud' disease,
had suffered from mental or neurological disorders

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Hospital of China Medical University		Shenyang	Liaoning	110001	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided