Comparing pain relief methods for shoulder surgery patients
A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)
PHASE4 · Endeavor Health · NCT05900427
This study is testing if a new pain relief method using liposomal bupivacaine can help people recovering from shoulder surgery feel better and use less opioid medication compared to the standard treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Endeavor Health (other) |
| Locations | 1 site (Skokie, Illinois) |
| Trial ID | NCT05900427 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of liposomal bupivacaine in interscalene blocks for patients undergoing total shoulder arthroplasty. It is a prospective randomized, double-blinded, controlled trial enrolling 130 subjects who will be assigned to receive either standard bupivacaine or a combination of liposomal bupivacaine and bupivacaine. The study will assess pain scores, quality of recovery, and opioid use at various postoperative intervals. The goal is to determine if liposomal bupivacaine can provide better pain management and reduce opioid consumption compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 who are undergoing total or reverse shoulder arthroplasty and weigh at least 60 kg.
Not a fit: Patients who are under 18 or over 90 years old, weigh less than 60 kg, or have contraindications to local anesthetics will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced opioid use for patients undergoing shoulder surgery.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of liposomal bupivacaine, indicating that this approach is still being explored for specific applications like shoulder surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject ages 18-90 years old * Male or Female subjects * Weight ≥ 60 kg. * Must be able to consent in English Exclusion Criteria: * Ages: \<18 and \>90 * Weight \< 60 kg * Multiple surgeries during one hospital stay * Emergency surgery * Allergy or any contraindication to local anesthetics used in trial. * Pregnancy * Contraindicated for use of liposomal bupivacaine * Severe liver/kidney disease * Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis * Subject who received another local anesthetic block prior to the interscalene block. * Unable to consent in English
Where this trial is running
Skokie, Illinois
- NorthShore University HealthSystem — Skokie, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Johnny K Lee, MD — Endeavor Health
- Study coordinator: Johnny K Lee, MD
- Email: JLee8@northshore.org
- Phone: 847-570-2760
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.
Conditions: Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty