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Pain Control Techniques for Shoulder Surgery Pain
N/A
Recruiting
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
American Society of Anesthesiologists (ASA) Physical Status I to III
Be older than 18 years old
Must not have
Severe respiratory disease
Coagulopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours (or until discharge)
Awards & highlights
Summary
This trial will compare two different ways of administering pain medication through a continuous nerve block for pain control after total shoulder arthroplasty. The first group will receive the medication through a traditional continuous infusion, and the second group will receive the medication through a new infusion strategy called the 'programmed intermittent bolus' (PIB) technique. The goal of the trial is to see if the PIB technique is better than the traditional continuous infusion with respect to pain control.
Who is the study for?
This trial is for adult patients undergoing shoulder replacement surgery who are in good to moderate health (ASA I-III). It's not suitable for those with chronic pain conditions, daily opioid use above a certain limit, drug allergies, blood clotting issues, severe lung disease, cognitive or psychiatric disorders that affect pain assessment, infections at the injection site, complex regional pain syndrome or a BMI over 40.Check my eligibility
What is being tested?
The study is testing if the 'programmed intermittent bolus' technique provides better postoperative pain control than traditional continuous infusion. Patients will be randomly assigned to receive one of these two methods during their continuous nerve block after shoulder arthroplasty.See study design
What are the potential side effects?
Potential side effects may include discomfort at the infusion site, possible nerve damage from the block placement procedure and side effects related to local anesthetics such as weakness or numbness around the area of administration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderately impaired according to ASA standards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe lung or breathing problem.
Select...
I have a blood clotting disorder.
Select...
I take more than 50 mg of morphine or its equivalent daily.
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I cannot communicate in English.
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I have a long-term pain condition like fibromyalgia or nerve pain.
Select...
I have been diagnosed with complex regional pain syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours (or until discharge)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours (or until discharge)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain score on 11 point (0 - 10) numeric rating scale
Secondary outcome measures
Block complication
Local anesthetic consumption
Opioid consumption
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Programmed Intermittent Bolus (PIB)Experimental Treatment1 Intervention
For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.
Group II: Continuous InfusionActive Control1 Intervention
The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Programmed Intermittent Bolus
2018
N/A
~50
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
666 Previous Clinical Trials
414,156 Total Patients Enrolled
3 Trials studying Pain Management
585 Patients Enrolled for Pain Management
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe lung or breathing problem.I cannot communicate in English.I have a long-term pain condition like fibromyalgia or nerve pain.My health is good to moderately impaired according to ASA standards.I have a blood clotting disorder.I take more than 50 mg of morphine or its equivalent daily.I am an adult.I have been diagnosed with complex regional pain syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Programmed Intermittent Bolus (PIB)
- Group 2: Continuous Infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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