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CompletedNCT03717753Updated Dec 27, 2024Results posted

Rotator Cuff Pathway

An interventional study of Pathway in Shoulder Pain, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Pain

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 140 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
140 participants (actual)

Study arms

  • 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

Interventions

  • OtherPathway

    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.

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What researchers measure

Primary outcomes

  1. Primary Outcome - Worst NRS With Movement

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

    Time frame: 0-48 hours after block placement

Secondary outcomes

  1. Total Opioid Use

    The total opioid consumption measured in morphine milligram equivalents (MME). Although recorded at different time points, the total MME per patient was calculated.

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

  2. Patient Satisfaction With Pain Management

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

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

  3. Pain Score at Rest

    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.

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

  4. Block Duration

    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

    Time frame: Through Post Op Day 2

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Results

Posted Jan 11, 2023

Participant flow

Participant flow — Overall Study
MilestoneBefore GroupAfter Group
Started7070
Completed7070
Not completed00

Outcome measures

PrimaryPrimary Outcome - Worst NRS With Movement

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

Time frame:
0-48 hours after block placement
Reported as:
Mean · score on a scale
Primary Outcome - Worst NRS With Movement
score on a scaleBefore GroupAfter Group
Post-Op Day 15.6 ± 33.3 ± 3.1
Post-Op Day 26.1 ± 2.76.4 ± 2.5
SecondaryTotal Opioid Use

The total opioid consumption measured in morphine milligram equivalents (MME). Although recorded at different time points, the total MME per patient was calculated.

Time frame:
Post Op Days 1,2,7,14
Reported as:
Median · morphine equivalent units (mg)
Total Opioid Use
morphine equivalent units (mg)Before GroupAfter Group
0-24 hours15 (7.5 to 30)0 (0 to 7.5)
24-48 hours22.5 (15 to 45)15 (7.5 to 30)
POD70 (0 to 7.5)0 (0 to 0)
POD140 (0 to 0)0 (0 to 0)
SecondaryPatient Satisfaction With Pain Management

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

Time frame:
Post Op Days 1,2,7,14
Reported as:
Mean · score on a scale
Patient Satisfaction With Pain Management
score on a scaleBefore GroupAfter Group
POD09.6 ± 1.49.5 ± 1.6
POD18.2 ± 2.59.2 ± 1.7
POD28.6 ± 1.68.8 ± 1.8
POD78.7 ± 1.59.1 ± 1.7
POD149 ± 1.39.1 ± 1.7
SecondaryPain Score at Rest

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.

Time frame:
Post Op Days 1,2,7,14
Reported as:
Mean · score on a scale of
Pain Score at Rest
score on a scale ofBefore GroupAfter Group
Post-Op Day 14.0 ± 2.91.9 ± 2.3
Post-Op Day 24.2 ± 2.14.7 ± 2.8
Post-Op Day 72.3 ± 2.13 ± 2.4
Post-Op Day 142.2 ± 1.91.7 ± 1.4
SecondaryBlock Duration

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

Time frame:
Through Post Op Day 2
Reported as:
Median · hours
Block Duration
hoursBefore GroupAfter Group
Time to first notice pain21.1 (13.9 to 23.6)25.4 (22.8 to 27.8)
Time to block start to wear off20.1 (13.9 to 23.4)23.2 (18.3 to 26.9)
Time to block to completely wear off22.7 (17.3 to 24.6)28.4 (24.9 to 33.1)
Time to normal sensation22.8 (17.7 to 26)28.6 (25.1 to 36.7)

Adverse events

Collected over Up to postoperative day 14.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Before Group0/70 (0%)0/70 (0%)0/70 (0%)
After Group0/70 (0%)0/70 (0%)0/70 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Before GroupAfter GroupTotal
Mean55 ± 1259 ± 1057 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Before GroupAfter GroupTotal
Female283260
Male423880
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Before GroupAfter GroupTotal
Hispanic or Latino213
Not Hispanic or Latino6669135
Unknown or Not Reported202
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Before GroupAfter GroupTotal
American Indian or Alaska Native000
Asian325
Native Hawaiian or Other Pacific Islander000
Black or African American347
White6259121
More than one race033
Unknown or Not Reported224
Region of Enrollment
Region of Enrollment(participants)Before GroupAfter GroupTotal
United States7070140
ASA Level
ASA Level(Participants)Before GroupAfter GroupTotal
ASA I171229
ASA II5153104
ASA III257
BMI
BMI(kg/m^2)Before GroupAfter GroupTotal
Mean27.8 ± 5.128.2 ± 4.228.0 ± 4.7
Procedure Time
Procedure Time(minutes)Before GroupAfter GroupTotal
Mean47 ± 1657 ± 1852 ± 18

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Hospital of Special Surgery
    New York, New York 10021, United States
09

References and documents

Publications

  • 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. PubMed 33720071 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 22, 2018

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03717753
Lead sponsor
Hospital for Special Surgery, New York
Responsible party
Sponsor
First posted
Oct 24, 2018
Start date
Sep 7, 2018
Primary completion
Jan 26, 2020
Completion
Mar 1, 2020
Results posted
Jan 11, 2023
Last update
Dec 27, 2024

Study contacts

Jacques YaDeau
principal investigator · Hospital for Special Surgery, New York

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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