N/A
N=140
Rotator Cuff Pathway
Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT03717753 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Primary Outcome - Worst NRS With Movement — 5.6; 3.3; 6.1; 6.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pathway (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome - Worst NRS With Movement |
5.6; 3.3; 6.1; 6.4 | — |
| SECONDARY Total Opioid Use |
15; 0; 22.5; 15; 0; 0 | — |
| SECONDARY Patient Satisfaction With Pain Management |
9.6; 9.5; 8.2; 9.2; 8.6; 8.8 | — |
| SECONDARY Pain Score at Rest |
4.0; 1.9; 4.2; 4.7; 2.3; 3 | — |
| SECONDARY Block Duration |
21.1; 25.4; 20.1; 23.2; 22.7; 28.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ambulatory rotator cuff patients with participating surgeons.
Includes the following concomitant procedures:
- Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair
- Arthroscopic Stabilization
- Arthroscopic AC (Acromioclavicular) resection
- Arthroscopic SAD (Sub-Acromial Decompression)
- Arthroscopic or mini open biceps tenodesis
- Age 18-80
Exclusion Criteria
- chronic pain history (defined as use of opioids > 3 months or current gabapentinoids for pain)
- open surgery (but sub pectoralis mini open biceps tenodesis is not excluded)
- revision surgery
- kidney disease (GFR < 60 ml/min/1.73 m2 for 3 months or more)
- liver disease (transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy)
- planned avoidance of regional anesthesia
- any contraindication to or patient refusal of any component in the pathway
- Non-English speakers
Data sourced from ClinicalTrials.gov (NCT03717753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.