Rotator Cuff Pathway
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pathway
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
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
Sites / Locations
- Hospital of Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Before Group
After Group
Arm Description
We plan to have 70 patients studied prior to initiation of a pathway.
We plan to have 70 patients studied after initiation of a pathway.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
Full Information
NCT ID
NCT03717753
First Posted
September 12, 2018
Last Updated
September 14, 2023
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT03717753
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
January 26, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Before Group
Arm Type
No Intervention
Arm Description
We plan to have 70 patients studied prior to initiation of a pathway.
Arm Title
After Group
Arm Type
Experimental
Arm Description
We plan to have 70 patients studied after initiation of a pathway.
Intervention Type
Other
Intervention Name(s)
Pathway
Intervention Description
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 Outcome Measure Information:
Title
Primary Outcome - Worst NRS With Movement
Description
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 Outcome Measure Information:
Title
Total Opioid Use
Description
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
Title
Patient Satisfaction With Pain Management
Description
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
Title
Pain Score at Rest
Description
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
Title
Block Duration
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques YaDeau
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33720071
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.
Results Reference
derived
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Rotator Cuff Pathway
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