Enhanced Recovery After Surgery, Spine Surgery
Conditions
Brief summary
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.
Interventions
OTHEREnhanced Recovery Pathway (ERP) for Spine
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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any patient presenting for 1 or 2 level posterior lumbar fusion.
Exclusion criteria
* Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate). * Kidney disease: GFR \<60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012). * Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy. * Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease). * Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol. * Patients whose primary or preferred language is not English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Score on QoR40 Inventory. | Postoperative Day 3 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Control: Opioid Consumption. | 48 hours after surgery | Measured in morphine equivalents daily. |
| Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1 | Postoperative Day 1 | Scale of 0-10, 0 being no pain, 10 being the worst pain possible |
| Time to Post-operative Oral Intake. | Postoperative Day 1 | Measured in hours |
| Number of Participants With Post-operative Nausea, Vomiting and Ileus | Postoperative Day 5 | If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge |
| Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Postoperative Day 5 | Measured in days after surgery (in half-day increments). |
| 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 | Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5) | Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge. |
| Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Days 0, 1, and 3 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Recovery Pathway An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution. | 25 |
| 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. | 26 |
| Total | 51 |
Baseline characteristics
| Characteristic | Enhanced Recovery Pathway | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 18.1 | 54.5 years STANDARD_DEVIATION 15.8 | 54.2 years STANDARD_DEVIATION 13.7 |
| ASA Level ASA I | 6 Participants | 12 Participants | 6 Participants |
| ASA Level ASA II | 18 Participants | 37 Participants | 19 Participants |
| ASA Level ASA III | 1 Participants | 2 Participants | 1 Participants |
| BMI | 27.1 kg/m^2 STANDARD_DEVIATION 4.2 | 28.26 kg/m^2 STANDARD_DEVIATION 4.89 | 29.4 kg/m^2 STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 49 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 24 Participants | 46 Participants | 22 Participants |
| Sex: Female, Male Female | 11 Participants | 29 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 22 Participants | 8 Participants |
| Surgery Fusion Level Fusion Level I | 21 Participants | 42 Participants | 21 Participants |
| Surgery Fusion Level Fusion Level II | 4 Participants | 9 Participants | 5 Participants |
| Total Anesthesia Time | 269 minutes STANDARD_DEVIATION 57 | 268.76 minutes STANDARD_DEVIATION 59.91 | 268.5 minutes STANDARD_DEVIATION 63.8 |
| Total Surgery Time | 183.2 minutes STANDARD_DEVIATION 54 | 187.84 minutes STANDARD_DEVIATION 58 | 192.3 minutes STANDARD_DEVIATION 62.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 |
Outcome results
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).
Time frame: Postoperative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Patient Score on QoR40 Inventory. | 179.4 scores on a scale | Standard Deviation 13.79 |
| Usual Care | Patient Score on QoR40 Inventory. | 170.3 scores on a scale | Standard Deviation 15.49 |
Secondary
Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.
Measured in days after surgery (in half-day increments).
Time frame: Postoperative Day 5
Population: One patient did not meet physical therapy goals
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Length of Stay | 2.8 days |
| Enhanced Recovery Pathway (ERP) for Spine | Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Time to meet physical therapy goals | 1.4 days |
| Usual Care | Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Length of Stay | 3.1 days |
| Usual Care | Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Time to meet physical therapy goals | 1.9 days |
Secondary
Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
Time frame: Postoperative Days 0, 1, and 3
Population: Patients who were discharged before Postoperative Day 3 did not have data collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Day 0 | 6.3 mcg/dl |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Day 1 | 0.5 mcg/dl |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Day 3 | 8.3 mcg/dl |
| Usual Care | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Day 0 | 5.4 mcg/dl |
| Usual Care | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Day 1 | 0.5 mcg/dl |
| Usual Care | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Day 3 | 8.9 mcg/dl |
Secondary
Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
Time frame: Postoperative Days 0, 1, and 3
Population: Patients discharged before postoperative day 3 did not have data collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Day 0 | 0.4 mg/dL |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Day 1 | 1.6 mg/dL |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Day 3 | 6.1 mg/dL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Day 0 | 0.4 mg/dL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Day 1 | 1.6 mg/dL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Day 3 | 15.9 mg/dL |
Secondary
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
Time frame: Postoperative Days 0, 1, and 3
Population: Patients who were discharged before Postoperative Day 3 did not have data collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Day 0 | 2.5 pg/mL |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Day 1 | 5 pg/mL |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Day 3 | 8 pg/mL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Day 0 | 2.5 pg/mL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Day 1 | 5 pg/mL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Day 3 | 8 pg/mL |
Secondary
Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
Time frame: Postoperative Days 0, 1, and 3
Population: Patients discharged before postoperative day 3 did not have data collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Day 0 | 8 uIU/mL |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Day 1 | 15 uIU/mL |
| Enhanced Recovery Pathway (ERP) for Spine | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Day 3 | 18 uIU/mL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Day 0 | 10 uIU/mL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Day 1 | 14 uIU/mL |
| Usual Care | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Day 3 | 15.5 uIU/mL |
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
Time frame: Postoperative Day 5
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Number of Participants With Post-operative Nausea, Vomiting and Ileus | Nasea | 8 Participants |
| Enhanced Recovery Pathway (ERP) for Spine | Number of Participants With Post-operative Nausea, Vomiting and Ileus | Vomiting | 3 Participants |
| Enhanced Recovery Pathway (ERP) for Spine | Number of Participants With Post-operative Nausea, Vomiting and Ileus | Ileus | 4 Participants |
| Usual Care | Number of Participants With Post-operative Nausea, Vomiting and Ileus | Nasea | 13 Participants |
| Usual Care | Number of Participants With Post-operative Nausea, Vomiting and Ileus | Vomiting | 2 Participants |
| Usual Care | Number of Participants With Post-operative Nausea, Vomiting and Ileus | Ileus | 6 Participants |
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.
Time frame: Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | Delirium/Confusion | 1 Participants |
| Enhanced Recovery Pathway (ERP) for Spine | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | Infection | 1 Participants |
| Enhanced Recovery Pathway (ERP) for Spine | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | DVT/PE | 1 Participants |
| Usual Care | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | Delirium/Confusion | 2 Participants |
| Usual Care | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | Infection | 0 Participants |
| Usual Care | Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE | DVT/PE | 0 Participants |
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
Time frame: Postoperative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1 | 3 units on a scale |
| Usual Care | Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1 | 4 units on a scale |
Secondary
Pain Control: Opioid Consumption.
Measured in morphine equivalents daily.
Time frame: 48 hours after surgery
Population: Patients who were discharged between the 24-48 hour time mark did not have data collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Pain Control: Opioid Consumption. | 0-24 Hours | 61.8 morphine equivalents daily |
| Enhanced Recovery Pathway (ERP) for Spine | Pain Control: Opioid Consumption. | 24-48 Hours | 30 morphine equivalents daily |
| Usual Care | Pain Control: Opioid Consumption. | 0-24 Hours | 133.2 morphine equivalents daily |
| Usual Care | Pain Control: Opioid Consumption. | 24-48 Hours | 75 morphine equivalents daily |
Secondary
Time to Post-operative Oral Intake.
Measured in hours
Time frame: Postoperative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Recovery Pathway (ERP) for Spine | Time to Post-operative Oral Intake. | 5.1 hours |
| Usual Care | Time to Post-operative Oral Intake. | 7.9 hours |