NCT01054378

Brief Summary

The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will be easily detected by M-mode ultrasonography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

January 21, 2010

Last Update Submit

December 6, 2010

Conditions

Head PainNeck PainShoulder PainArm PainNeural Sensory Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • The amplitude of diaphragm movement before and after SGB during quiet breathing, deep breathing and voluntary sniff, inspiratory time and expiratory time, oxygen saturation

    The ultrasonographic evaluation will take place just before and 30 minutes after stellate ganglion block.

Interventions

M-mode ultrasonographyPROCEDURE

Evaluation of diaphragmatic movement using M-mode ultrasonography before and after stellate ganglion block with 1% lidocaine

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory neural hearing loss

You may not qualify if:

  • coagulopathy, pulmonary disease, neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

HeadacheNeck PainShoulder Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Duck Mi Yoon

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

KR(1)