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Rotator Cuff Pathway

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717753
Recruitment Status : Enrolling by invitation
First Posted : October 24, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Other: Pathway Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : September 7, 2020
Estimated Study Completion Date : September 7, 2022
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Before Group
We plan to have 70 patients studied prior to initiation of a pathway.
Experimental: After Group
We plan to have 70 patients studied after initiation of a pathway.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome - Worst NRS with movement [ Time Frame: 0-48 hours after block placement ]
    worst NRS with movement


Secondary Outcome Measures :
  1. Total Opioid Use [ Time Frame: Post Op Days 1,2,7,14 ]
    Total Opioid Use

  2. Patient Satisfaction With Pain Management on scale 0-10 [ Time Frame: Post Op Days 1,2,7,14 ]
    Satisfaction with Pain Management

  3. Pain Score at Rest [ Time Frame: Post Op Days 1,2,7,14 ]
  4. Block Duration [ Time Frame: Through Post Op Day 2 ]
  5. Selected Patient Oriented Pain Questionnaire [ Time Frame: Post Op Days 1,2,7,14 ]
  6. Patient and Physician Adherence to Pathway [ Time Frame: Post Op Days 1,2,7,14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717753


Locations
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United States, New York
Hospital of Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Jacques YaDeau Hospital for Special Surgery, New York
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03717753    
Other Study ID Numbers: 2018-0814
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations