Rotator Cuff Pathway

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Completed

Conditions

Shoulder Pain

Treatments

Other: Pathway

Study type

Interventional

Funder types

Other

Identifiers

NCT03717753
2018-0814 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

140 participants in 2 patient groups

Before Group
No Intervention group
Description:
We plan to have 70 patients studied prior to initiation of a pathway.
After Group
Experimental group
Description:
We plan to have 70 patients studied after initiation of a pathway.
Treatment:
Other: Pathway

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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