NCT03677115

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

4.4 years

First QC Date

September 16, 2018

Last Update Submit

November 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of analgesia duration

    Change of thoracic paravertebral block analgesia duration

    Change from Baseline to 3 days after surgery

Study Arms (1)

dexmedetomidine group

EXPERIMENTAL

a combination of ropivacaine and dexmedetomidine

Drug: Dexmedetomidine

Interventions

combination of ropivacaine and dexmedetomidine 20 ug every time

dexmedetomidine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: a single-dose thoracic paravertebral analgesia for postoperative pain control after thoracoscopic lobectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2018

First Posted

September 19, 2018

Study Start

November 1, 2018

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

November 12, 2021

Record last verified: 2021-11

Locations