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Completed

NCT Number: NCT03717753

Rotator Cuff Pathway

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pathway

Other

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.

Primary outcomes

  1. Primary Outcome - Worst NRS With Movement

    Time frame: 0-48 hours after block placement

    worst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10.

Secondary outcomes

  1. Total Opioid Use

    Time frame: Post Op Days 1,2,7,14

    The total opioid consumption measured in morphine milligram equivalents (MME).

    Although recorded at different time points, the total MME per patient was calculated.

  2. Patient Satisfaction With Pain Management

    Time frame: Post Op Days 1,2,7,14

    Measures the patient's satisfaction with their pain management on a scale of 0-10. A higher score is a better outcome.

  3. Pain Score at Rest

    Time frame: Post Op Days 1,2,7,14

    a NRS score on a scale from 0 to 10. 0 means no pain and 10 is the worst pain imaginable. A lower score is a better outcome.

  4. Block Duration

    Time frame: Through Post Op Day 2

    Measures the duration of the block from:

    the time the block started to the time the block completely wore off the time the block started to the time the patient first noticed pain the time the block started to the time the patient felt normal sensation

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2018
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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