Incidence of Hemidiaphragmatic Palsy After Interscalene Block

NCT01784601 | Suspended DMC

• 1 other identifier: 103337
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Phrenic Nerve Paralysis

Keywords

Interscalene block; Hemidiaphragm palsy

Outcome Measures

Primary Outcomes (1)

• 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 (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.

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Study Officials

• Shalini Dhir, FRCPC

  St. Joseph's Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesia

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 6, 2013
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

CA (1)