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Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery Pathway for Spine | Experimental |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Other | The study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Score on QoR40 Inventory. | The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). | Postoperative Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Measured in days after surgery (in half-day increments). | Postoperative Day 5 |
| Pain Control: Opioid Consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Soffin, MD, PhD | Hospital for Special Surgery, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Recovery Pathway | An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgeryâ„¢ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution. |
| FG001 | Usual Care | Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Recovery Pathway | An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgeryâ„¢ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution. |
| BG001 |
| 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 | Patient Score on QoR40 Inventory. | The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). | Posted | Mean | Standard Deviation | scores on a scale | Postoperative Day 3 |
|
Adverse Events were collected during their length of stay in the hospital (which as at most up to 5 days) after surgery.
The risks of collecting plasma for this study are similar to the risks of a routine blood draw, including - mild pain, bruising, and very rarely infection at the place of needle insertion. However, the likelihood of these risks occurring is rare, as an arterial line catheter is routinely placed in patients undergoing this class of spine surgery in order to continuously monitor the patient's hemodynamics perioperatively. The study team expected to draw samples using the pre-existing catheter.
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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 | Enhanced Recovery Pathway | An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgeryâ„¢ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Soffin | Hospital for Special Surgery | 212-606-1206 | soffine@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 | May 4, 2020 | May 22, 2020 | Prot_SAP_000.pdf |
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|
Measured in morphine equivalents daily.
| 48 hours after surgery |
| Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1 | Scale of 0-10, 0 being no pain, 10 being the worst pain possible | Postoperative Day 1 |
| Time to Post-operative Oral Intake. | Measured in hours | Postoperative Day 1 |
| Number of Participants With Post-operative Nausea, Vomiting and Ileus | If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge | Postoperative Day 5 |
| Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Days 0, 1, and 3 |
| Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Days 0, 1, and 3 |
| Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Days 0, 1, and 3 |
| Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Days 0, 1, and 3 |
| Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge. | Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5) |
| Usual Care |
Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ASA Level | ASA 1: A normal healthy patient. ASA 2: A patient with a mild systemic disease. ASA 3: A patient with a severe systemic disease that is not life-threatening. | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Total Anesthesia Time | Mean | Standard Deviation | minutes |
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| Total Surgery Time | Mean | Standard Deviation | minutes |
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| Surgery Fusion Level | Type of Surgery - either 1 Level or 2 Level Spine Fusion was done. Fusion of only one motion segment of the spine (e.g. L5-S1) is referred to as a 1 level fusion. 2-level fusion may be considered for patients with severe, disabling pain that occurs at two levels of the spine (e.g. L4-L5 and L5-S1). | Count of Participants | Participants |
|
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment |
|
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| Secondary | Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Measured in days after surgery (in half-day increments). | One patient did not meet physical therapy goals | Posted | Median | Inter-Quartile Range | days | Postoperative Day 5 |
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|
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| Secondary | Pain Control: Opioid Consumption. | Measured in morphine equivalents daily. | Patients who were discharged between the 24-48 hour time mark did not have data collected. | Posted | Median | Inter-Quartile Range | morphine equivalents daily | 48 hours after surgery |
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| Secondary | Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1 | Scale of 0-10, 0 being no pain, 10 being the worst pain possible | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative Day 1 |
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| Secondary | Time to Post-operative Oral Intake. | Measured in hours | Posted | Median | Inter-Quartile Range | hours | Postoperative Day 1 |
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| Secondary | Number of Participants With Post-operative Nausea, Vomiting and Ileus | If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge | Posted | Count of Participants | Participants | Postoperative Day 5 |
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| Secondary | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Patients who were discharged before Postoperative Day 3 did not have data collected. | Posted | Median | Inter-Quartile Range | pg/mL | Postoperative Days 0, 1, and 3 |
|
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| Secondary | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Patients who were discharged before Postoperative Day 3 did not have data collected. | Posted | Median | Inter-Quartile Range | mcg/dl | Postoperative Days 0, 1, and 3 |
|
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| Secondary | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Patients discharged before postoperative day 3 did not have data collected. | Posted | Median | Inter-Quartile Range | mg/dL | Postoperative Days 0, 1, and 3 |
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|
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| Secondary | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Patients discharged before postoperative day 3 did not have data collected. | Posted | Median | Inter-Quartile Range | uIU/mL | Postoperative Days 0, 1, and 3 |
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| Secondary | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge. | Posted | Count of Participants | Participants | Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5) |
|
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|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Usual Care | Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions. | 0 | 26 | 0 | 26 | 0 | 26 |
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| Time to meet physical therapy goals |
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| 24-48 Hours |
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| Ileus |
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| Postoperative Day 1 |
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| Postoperative Day 3 |
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| Postoperative Day 1 |
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| Postoperative Day 3 |
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| Postoperative Day 1 |
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| Postoperative Day 3 |
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| Postoperative Day 1 |
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| Postoperative Day 3 |
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| DVT/PE |
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