Postoperative infusion pump versus nerve block for pain after knee or shoulder surgery
Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery
This study will try a postoperative local anesthetic infusion pump versus a preoperative nerve block to see which reduces pain for adults having ACL, shoulder labrum/rotator cuff, or certain knee surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Somerset, New Jersey) |
| Trial ID | NCT07349810 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, prospective cluster-randomized trial that assigns treatment approach by sequential two-week time clusters. Adults undergoing ACL reconstruction, specified shoulder labrum or rotator cuff procedures, arthroscopic rotator cuff repair, patellar realignment, or selected open knee arthrotomies at the University Center for Ambulatory Surgery in Somerset, NJ, will be screened and consented. Interventions include continuous infusion via an ambIT pump using bupivacaine or ropivacaine and use of liposomal bupivacaine (Exparel) where applicable, and pain will be measured using visual analog or numeric pain scores as the primary outcome. The trial compares postoperative infusion pump versus preoperative peripheral nerve block to determine which provides better postoperative analgesia.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for the listed ACL, shoulder, or qualifying knee procedures at the study site are the intended participants.
Not a fit: Patients younger than 18, with BMI over 40, ASA class 4 or greater, chronic opioid use, allergy to bupivacaine/ropivacaine, coagulation disorders, or other listed exclusions are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, it could reduce postoperative pain and opioid use after common knee and shoulder surgeries.
How similar studies have performed: Prior research on continuous local anesthetic infusions and liposomal bupivacaine in orthopedic surgeries has produced mixed results, with some studies showing reduced pain and opioid use but inconsistent long-term benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * ACL reconstruction * Open shoulder labrum or rotator cuff surgery * Arthroscopic rotator cuff repair * Proximal or distal patellar realignment surgery * Open knee arthrotomy cases - Inside out meniscus repair, OCA, MAT Exclusion Criteria: * Age under 18 years * Body mass index of greater than 40 kg/m2 * American Society of Anesthesiologist class 4 physical status or greater * History of drug or alcohol abuse * Chronic opioid use/pain management doctor * Allergy to bupivacaine, ropivacaine or pharmacologic analogs * Any coagulation disorders * Existing nerve injury * Severe bronchopulmonary disease * Pregnant patients
Where this trial is running
Somerset, New Jersey
- University Center for Ambulatory Surgery — Somerset, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Charles Gatt, MD
- Email: cjgatt85@gmail.com
- Phone: 732-537-0909
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.