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Incidence of Hemidiaphragmatic Palsy After Interscalene Block

This study is currently recruiting participants.
Verified February 2017 by Shalini Dhir, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01784601
First Posted: February 6, 2013
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute
  Purpose

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.

Condition
Phrenic Nerve Paralysis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Incidence of Hemidiaphragmatic Palsy After Single Shot Interscalene Block for Pain Relief in Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Shalini Dhir, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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: [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ]

Estimated Enrollment: 200
Actual Study Start Date: December 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Control Group:

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

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784601


Contacts
Contact: Shalini Dhir, MD, FRCPC 519 6466000 ext 64219 shalini.dhir@sjhc.london.on.ca

Locations
Canada, Ontario
St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Shalini Dhir, FRCPC    519 6466000 ext 64219    shalini.dhir@sjhc.london.on.ca   
Principal Investigator: Shalini Dhir, MD, FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shalini Dhir, FRCPC St. Joseph's Health Care
  More Information

Responsible Party: Shalini Dhir, Associate Professor, Department of Anaesthesia, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01784601     History of Changes
Other Study ID Numbers: 103337
First Submitted: February 1, 2013
First Posted: February 6, 2013
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Shalini Dhir, Lawson Health Research Institute:
Interscalene block
Hemidiaphragm palsy

Additional relevant MeSH terms:
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms