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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-48 hours after block placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post Op Days 1,2,7,14 |
| Patient Satisfaction With Pain Management |
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Inclusion Criteria:
Includes the following concomitant procedures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques YaDeau | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33720071 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Before Group | We plan to have 70 patients studied prior to initiation of a pathway. |
| FG001 | After Group | We plan to have 70 patients studied after initiation of a pathway. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Before Group | We plan to have 70 patients studied prior to initiation of a pathway. |
| BG001 | After Group | We plan to have 70 patients studied after initiation of a pathway. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 0-48 hours after block placement |
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Up to postoperative day 14.
This was an observational study so no adverse events were reported. Only post-operative complications were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Before Group | We plan to have 70 patients studied prior to initiation of a pathway. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques YaDeau, MD PhD | Hospital for Special Surgery | 212- 606-1206 | yadeauj@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2018 | Feb 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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|
Measures the patient's satisfaction with their pain management on a scale of 0-10. A higher score is a better outcome.
| 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. | 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 | Through Post Op Day 2 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ASA Level | The ASA Physical Status Classification System has been in use for over 60 years. The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning), it can be helpful in predicting perioperative risks. A lower classification is a better "healthier" individual. ref: https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Procedure Time | Mean | Standard Deviation | minutes |
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| Rotator Cuff Repair Performed | Count of Participants | Participants |
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| Secondary | 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. | some patients were lost to follow up. | Posted | Median | Inter-Quartile Range | morphine equivalent units (mg) | Post Op Days 1,2,7,14 |
|
|
|
| Secondary | 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. | Some patients were lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Post Op Days 1,2,7,14 |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale of | Post Op Days 1,2,7,14 |
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| Secondary | 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 | Some patients were lost to follow up | Posted | Median | Inter-Quartile Range | hours | Through Post Op Day 2 |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | After Group | We plan to have 70 patients studied after initiation of a pathway. 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. | 0 | 70 | 0 | 70 | 0 | 70 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 24-48 hours |
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| POD7 |
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| POD14 |
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| POD1 |
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| POD2 |
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| POD7 |
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| POD14 |
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| Post-Op Day 7 |
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| Post-Op Day 14 |
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| Time to block start to wear off |
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| Time to block to completely wear off |
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| Time to normal sensation |
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