Treatment for Rotator Cuff Tears

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Alberta Hospital, Edmonton, Canada
Rotator Cuff Tears+1 More
Eligibility
18+
All Sexes
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Study Summary

The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty

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Eligible Conditions

  • Rotator Cuff Tears
  • Anesthesia; Functional

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 10 secondary outcomes in patients with Rotator Cuff Tears. Measurement will happen over the course of Intraoperative period.

1st postoperative hour
Sensory testing of nerves in the distribution of the nerve block ("Cold test")
The sedation score in PACU
Intraoperative measurement
Intraoperative heart rate
Intraoperative opioid use
Intraoperative measurement done at the end of anesthetic
Average age-adjusted MAC of sevoflurane
Intraoperative period
Intraoperative mean blood pressure
Intraoperative vasopressor usage
Up to 24 postoperative hours
24 hour opioid consumption
Maximum pain scores in the first 24 post-operative hours
Nausea and vomiting in the first 24 post-operative hours
Postoperative opioid use in PACU

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

PRE-GA
1 of 2
POST-GA
1 of 2
Active Control
Non-Treatment Group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

POST-GA10 ml of 5% dextrose injection before the start of surgery and 1% ropivacaine injection at the end of surgery through the interscalene catheter
PRE-GA10 mL of 1% ropivacaine injection before the start of surgery and 10 ml of 5% dextrose injection at the end of surgery through the interscalene catheter

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 postoperative hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 postoperative hours for reporting.

Closest Location

University of Alberta Hospital - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients undergoing elective shoulder arthroscopy
Patients eligible for interscalene brachial plexus block
All adults 18 years of age or older
Capable to give consent

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Rotator Cuff Tears by sharing your contact details with the study coordinator.