NCT03933228

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

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

April 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

2.6 years

First QC Date

April 28, 2019

Last Update Submit

April 8, 2024

Conditions

Clavicular Fractures

Keywords

Combined Interscalene-Cervical Plexus BlockCombined Supraclavicular-Cervical Plexus Block

Outcome Measures

Primary Outcomes (1)

  • Block success rate

    Sensory blockade was assessed using the pinprick test at the surgery site

    At time 15 minutes after the block

Secondary Outcomes (1)

  • Acute complications

    At the end of surgery immediately

Study Arms (2)

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

Interscalene-Cervical Plexus BlockPROCEDURE

Ultrasound-Guided Combined Interscalene-Cervical Plexus Block

Interscalene-Cervical Plexus Block
Supraclavicular-Cervical Plexus BlockPROCEDURE

Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block

Supraclavicular-Cervical Plexus Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

150

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, 061001, China

Location

Study Officials

  • Ruizhao Lv, M.D

    Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2019

First Posted

May 1, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

CN(1)