Shoulder PainNCT03717753
Rotator Cuff Pathway
A study testing Pathway in people with Shoulder Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Hospital of Special Surgery
New York, New York, 10021
About this study
Official title: The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study
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.
- Conditions
- Shoulder Pain
- Being tested
- Pathway
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Before Group | No intervention | We plan to have 70 patients studied prior to initiation of a pathway. |
| After Group | Experimental | We plan to have 70 patients studied after initiation of a pathway. Receives: Other: Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-48 hours after block placement
Secondary outcomes (4)
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.
Measured: Post Op Days 1,2,7,14
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.
Measured: Post Op Days 1,2,7,14
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.
Measured: Post Op Days 1,2,7,14
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
Measured: Through Post Op Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start7 Sep 2018
- Primary completion26 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques YaDeau, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717753
- Sponsor's protocol ID
- 2018-0814
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2018
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study
- ClinicalTrials.gov ID
- NCT03717753
- Acronym / sponsor ID
- 2018-0814
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Posted 11 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Group | No intervention | –We plan to have 70 patients studied prior to initiation of a pathway. |
| After Group | Experimental | Other: PathwayWe plan to have 70 patients studied after initiation of a pathway. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ambulatory rotator cuff patients with participating surgeons.
- Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair
- Arthroscopic Stabilization
- Arthroscopic AC (Acromioclavicular) resection
- Arthroscopic SAD (Sub-Acromial Decompression)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PathwayThe 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. | Other | After Group |
Primary outcome
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.
4 secondary outcomes
Total Opioid Use
Time frame: Post Op Days 1,2,7,14
Patient Satisfaction With Pain Management
Time frame: Post Op Days 1,2,7,14
Pain Score at Rest
Time frame: Post Op Days 1,2,7,14
Block Duration
Time frame: Through Post Op Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33720071YaDeau 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.
Related trials for Shoulder Pain
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
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Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
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Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
Rotator Cuff Related Shoulder Pain, Rotator Cuff Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques YaDeau principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathway in people with Shoulder Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome - Worst NRS With Movement (time frame: 0-48 hours after block placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03717753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.