Clinical trial NCT03717753: Rotator Cuff Pathway
Official title: The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Primary Outcome - Worst NRS With Movement
timeFrame: 0-48 hours after block placement
Secondary outcomes:
measure: Total Opioid Use
timeFrame: Post Op Days 1,2,7,14
measure: Patient Satisfaction With Pain Management
timeFrame: Post Op Days 1,2,7,14
measure: Pain Score at Rest
timeFrame: Post Op Days 1,2,7,14
measure: Block Duration
timeFrame: Through Post Op Day 2
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital of Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques YaDeau
role: PRINCIPAL_INVESTIGATOR
References:
citation: YaDeau JT, Soffin EM, Tseng A, Zhong H, Dines DM, Dines JS, Gordon MA, Lee BH, Kumar K, Kahn RL, Kirksey MA, Schweitzer AA, Gulotta LV. A Comprehensive Enhanced Recovery Pathway for Rotator Cuff Surgery Reduces Pain, Opioid Use, and Side Effects. Clin Orthop Relat Res. 2021 Aug 1;479(8):1740-1751. doi: 10.1097/CORR.0000000000001684.