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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours (or until discharge)
Awards & highlights

Study 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 below
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My health is good to moderately impaired according to ASA standards.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours (or until discharge)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours (or until discharge) for reporting.

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 more

Trial 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
658 Previous Clinical Trials
413,548 Total Patients Enrolled
3 Trials studying Pain Management
585 Patients Enrolled for Pain Management

Media Library

Programmed Intermittent Bolus (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03268837 — N/A
Pain Management Research Study Groups: Programmed Intermittent Bolus (PIB), Continuous Infusion
Pain Management Clinical Trial 2023: Programmed Intermittent Bolus Highlights & Side Effects. Trial Name: NCT03268837 — N/A
Programmed Intermittent Bolus (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03268837 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to sign up for this investigation?

"Per the details provided on clinicaltrials.gov, this scientific investigation is in progress and actively recruiting participants after being first published on September 1st 2022 and last modified on September 26th of that same year."

Answered by AI

What is the uppermost patient count for this research project?

"Affirmative. Clinicaltrials.gov has information which affirms that this clinical trial, first shared on September 1st 2022, is actively recruiting participants. 110 individuals need to be recruited from a single site."

Answered by AI
~7 spots leftby Jul 2024