Phrenic Nerve ParalysisNCT01784601
Incidence of Hemidiaphragmatic Palsy After Interscalene Block
An observational study of Phrenic Nerve Paralysis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Phrenic Nerve Paralysis
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Control Group: We will be including all patients undergoing shoulder surgery not scheduled for a nerve block.
Who may be able to join
- Control Group:
- Age between 18 - 80 years old Elective shoulder surgery Same day discharge Inform consent signed
Who cannot join
- Ongoing Major psychiatric problems Narcotic Abuse/ Drug dependency Mental impairment / inability to cooperate with postoperative evaluation/Inability to give informed consent
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Hemidiaphragmatic Palsy After Single Shot Interscalene Block for Pain Relief in Shoulder Surgery
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.
Read the 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.
- Conditions
- Phrenic Nerve Paralysis
- Keywords
- Interscalene block, Hemidiaphragm palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startDec 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Lack of human resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phrenic Nerve ParalysisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, FRCPC, Principal investigator, St. Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784601
- Sponsor's protocol ID
- 103337
- Status last verified
- Oct 2023
- First submitted
- 1 Feb 2013
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hemidiaphragmatic Palsy After Single Shot Interscalene Block for Pain Relief in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01784601
- Acronym / sponsor ID
- 103337
- Conditions
- Phrenic Nerve Paralysis
- Keywords
- Interscalene block, Hemidiaphragm palsy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Lack of human resources
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Control Group: We will be including all patients undergoing shoulder surgery not scheduled for a nerve block.
Key inclusion criteria (2 listed)
- Age between 18 - 80 years old Elective shoulder surgery Same day discharge Inform consent signed
Key exclusion criteria (2 listed)
- Ongoing Major psychiatric problems Narcotic Abuse/ Drug dependency Mental impairment / inability to cooperate with postoperative evaluation/Inability to give informed consent
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Related trials for Phrenic Nerve Paralysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Dhir, FRCPC principal investigator
St. Joseph's Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phrenic Nerve Paralysis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.