Incidence of Hemidiaphragmatic Palsy After Interscalene B... | NCT01784601

Studies
Incidence of Hemidiaphragmatic Palsy After Interscalene Block

NCT01784601

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Suspended

Last Update Posted

Oct 3, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Phrenic Nerve Paralysis

Interventions

Not provided

Countries

Canada

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of human resources

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 1, 2013

First Submission Date that Met QC Criteria

Feb 4, 2013

First Posted Date

Feb 6, 2013Estimated

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

Oct 2, 2023

Last Update Posted Date

Oct 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shalini Dhir, Associate Professor, Department of Anaesthesia, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance.

Primary hypothesis:

• There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an interscalene block.

Secondary hypothesis

The incidence of hemidiaphragmatic palsy is much less than 33% when the block is done using ultrasound.
The incidence of hemi-diaphragmatic palsy is directly proportional to volume of local anaesthetic injected.
The incidence of hemi-diaphragmatic palsy is directly proportional to concentration of local anaesthetic injected.

Detailed Description

Patients of either sex belonging to American Society of Anesthesiologists status 1-3 scheduled for elective shoulder surgery as an outpatient basis, planned for an interscalene block will be included in this study over a period of one year.

Potential patients will be identified from the surgeons' list. The PI or one of the co-investigators will contact them in the surgical day care in the morning of surgery and will be given information about the study. Documented informed consent will be obtained.

After obtaining informed consent, they will be examined for their diaphragm position using an ultrasound prior to block placement .

All patients will have the block initiated in the block room using standard monitors and sedation as per the standard practice in this hospital.

The patients will undergo an ultrasound examination for their diaphragm position 5 mins and 10 mins after the completion of the nerve block. Ipsilateral ( same side as the block) and contralateral ( opposite side of block) hemi-diaphragmatic excursion will be measured with the patients in supine position during quiet inspiration ,deep inspiration and forceful sniff.

In addition, bedside spirometry using a compact spirometer will be performed and FVC, FEV1 and PEFR measurements will be performed.The oxygen saturation and any evidence of dyspnea or shortness of breadth will be noted at the above mentioned intervals after the completion of the block.

All patients will receive general anesthesia in the operating room. The patient will receive IV opioids during the procedure if required.

The above mentioned data will be collected postoperatively in the recovery room 30 mins, after arrival.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		We will be including all patients undergoing shoulder surgery not scheduled for a nerve block.
Study Group		We will be including all patients undergoing shoulder surgery scheduled for a nerve block.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance. Primary hypothesis:	We intend to scan all patients undergoing ISB who consent to be part of the study, for the diaphragm excursion to find out the incidence at our institute.	1 year

Secondary Outcomes

Measure	Description	Time Frame
In addition we will also do Spirometric analysis and assess for symptomatic respiratory insufficiency/ distress. Thus we can find the incidence of clinically significant hemi-diaphragmatic palsy.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Control Group:

Age between 18 - 80 years old Elective shoulder surgery Same day discharge Inform consent signed

Exclusion Criteria:

Ongoing Major psychiatric problems Narcotic Abuse/ Drug dependency Mental impairment / inability to cooperate with postoperative evaluation/Inability to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Control Group:

We will be including all patients undergoing shoulder surgery not scheduled for a nerve block.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shalini Dhir, FRCPC	St. Joseph's Health Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Health Care		London	Ontario	N6A 4V2	Canada