Incidence of Hemidiaphragmatic Palsy After Interscalene Block
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|ClinicalTrials.gov Identifier: NCT01784601|
Recruitment Status : Unknown
Verified February 2017 by Shalini Dhir, Lawson Health Research Institute.
Recruitment status was: Recruiting
First Posted : February 6, 2013
Last Update Posted : February 14, 2017
Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance.
• There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an interscalene block.
- 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 or disease|
|Phrenic Nerve Paralysis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Incidence of Hemidiaphragmatic Palsy After Single Shot Interscalene Block for Pain Relief in Shoulder Surgery|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
We will be including all patients undergoing shoulder surgery not scheduled for a nerve block.
We will be including all patients undergoing shoulder surgery scheduled for a nerve block.
- 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.
- 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 ]
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
|Contact: Shalini Dhir, MD, FRCPC||519 6466000 ext email@example.com|
|St. Joseph's Health Care||Recruiting|
|London, Ontario, Canada, N6A 4V2|
|Contact: Shalini Dhir, FRCPC 519 6466000 ext 64219 firstname.lastname@example.org|
|Principal Investigator: Shalini Dhir, MD, FRCPC|
|Principal Investigator:||Shalini Dhir, FRCPC||St. Joseph's Health Care|