NCT03717753

Rotator Cuff Pathway

The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still experience moderate to severe pain after surgery, despite the use of regional anesthesia and opioids. The specific aim is to determine whether a comprehensive pathway that includes a well-defined regional technique and multimodal analgesia will reduce the worst pain with movement 0-48 hours after block placement compared to the current standard practice. This is a 'before and after' study. We plan to have 70 patients studied prior to initiation of a pathway, and 70 patients studied after initiation of a pathway. Both groups will receive identical postoperative follow-up.

Detailed description

Previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block and preemptive non-opioid analgesia (Goon et al. 2014). These surgeries were done as inpatient and patients had availability of intravenous opioids. Assessment of the current approach to managing rotator cuff repairs demonstrated an average worst pain score after surgery of 7.0, SD 2.1 (Kahn) which is often categorized as "severe" pain. Given that most rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway that mitigates the worst pain experienced after surgery. With outpatient surgery, there are obvious limitations regarding availability of rescue pain medications. Therefore, the pathway needs to emphasize patient education and strategies to reduce the pain as peripheral nerve block subsides. Given these issues, we believe there is an advantage to prolonging the analgesia from the nerve block (Rosenfeld et al. 2016, Yadeau et al. 2016, Kahn) and educating patients regarding the importance of preemptive analgesia and when to take opioid medications. This study will evaluate whether the clinical pathway might mitigate the worst pain after surgery that occurs with the current standard practice.

Conditions

• Shoulder Pain

Interventions

Type	Name	Description
OTHER	Pathway	The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components. Both groups will receive identical postoperative follow-up.

Timeline

• Start date: 2018-09-07
• Primary completion: 2020-01-26
• Completion: 2020-03-01
• First posted: 2018-10-24
• Last updated: 2024-12-27
• Results posted: 2023-01-11

Locations

1 site across 1 country: United States