NCT02814890

Brief Summary

The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

June 21, 2016

Results QC Date

August 29, 2017

Last Update Submit

August 5, 2020

Conditions

Pain, Postoperative

Keywords

Thoracic paravertebral blockDexmedetomidineVideo-assisted PneumonectomyRopivacainePain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain (Pain Scores) Intensity Measure

    Pain Numerical Rating Scales （NRS) at rest（0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)

    assessed over 48 hours after surgery, self reported pain intensity at 2 days reported

Secondary Outcomes (3)

  • Patient Satisfaction

    Hour 48 after surgery

  • Number of Participants With Postoperative Rescue Analgesic Administration

    Hour 24, Hour 48 after surgery

  • Adverse Events

    Hour 48 after surgery

Study Arms (2)

Ropivacaine and dexmedetomidine

EXPERIMENTAL

Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.

Procedure: Video-assisted PneumonectomyProcedure: Thoracic paravertebral block

Ropivacaine only

ACTIVE COMPARATOR

Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.

Procedure: Video-assisted PneumonectomyProcedure: Thoracic paravertebral block

Interventions

Video-assisted PneumonectomyPROCEDURE

Video-assisted Pneumonectomy under general anesthesia.

Ropivacaine and dexmedetomidineRopivacaine only
Thoracic paravertebral blockPROCEDURE

The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.

Also known as: Thoracic paravertebral nerve block
Ropivacaine and dexmedetomidineRopivacaine only

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-II grade
  • Undergoing elective video-assisted pneumonectomy under general anesthesia.
  • Participants aged from 30-70 years old.

You may not qualify if:

  • Refusal for paravertebral block
  • Inability to obtain informed consent
  • Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
  • Pregnancy
  • Infections at the site of injection for the paravertebral block
  • Allergy to local anesthetics or alpha-2 adrenergic agonists
  • Heart block or bradycardia (heart rate \< 60 beat per minute)
  • Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Dr. Jun Zhang
Organization
Huashan Hospital, Fudan University, Shanghai
snapzhang@aliyun.com
0086-021-52887694

Study Officials

  • Jun Zhang, MD,PhD

    Department of Anesthesiology,Huashan Hospital,Fudan University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 28, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 6, 2020

Results First Posted

August 6, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)