Clinical trial NCT01784601: Incidence of Hemidiaphragmatic Palsy After Interscalene Block
Official title: Incidence of Hemidiaphragmatic Palsy After Single Shot Interscalene Block for Pain Relief in Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Phrenic Nerve Paralysis
Keywords: Interscalene block
Hemidiaphragm palsy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control Group:

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

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.

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

-

Primary outcomes:
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:
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care
name: Shalini Dhir, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: