New pain management technique for shoulder surgery
Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial
This study tests a new way to manage pain after shoulder surgery to see if it works better than the usual method for helping patients feel more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT03268837 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a new pain management technique called the 'programmed intermittent bolus' (PIB) compared to traditional continuous infusion for patients undergoing total shoulder arthroplasty. The PIB technique delivers medication in a more rapid manner, potentially improving pain control and patient satisfaction. The study aims to determine if this method provides better postoperative analgesia when used in conjunction with a continuous nerve block. Participants will be randomly assigned to receive either the PIB or the traditional infusion method.
Who should consider this trial
Good fit: Ideal candidates include adult patients with an ASA Physical Status of I to III who are scheduled for total shoulder arthroplasty.
Not a fit: Patients with a BMI over 40, severe respiratory disease, or chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and satisfaction for patients undergoing shoulder surgery.
How similar studies have performed: Previous studies have shown success with the PIB technique in other settings, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients * American Society of Anesthesiologists (ASA) Physical Status I to III Exclusion Criteria: * Body mass index (BMI) \> 40 * Not able to communicate in ENglish * Unable to obtain consent * Infection over site of placement * Severe respiratory disease * Cognitive or psychiatric history that would make it difficult to assess pain score * Complex regional pain syndrome * Chronic pain condition such as fibromyalgia, neuropathic pain * Preoperative opioid use greater than the equivalent of morphine 50 mg PO daily * Allergy to any of the study drug * Coagulopathy
Where this trial is running
London, Ontario
- St. Joseph's Health Care London — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Bill Lin, FRCPC
- Email: cheng.lin@lhsc.on.ca
- Phone: +15196466000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.