Enhanced Recovery After Spine Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion

Conditions
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Enhanced Recovery After Surgery, Spine Surgery

Intervention / Treatment
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* Other: Enhanced Recovery Pathway (ERP) for Spine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Recovery Pathway for Spine<br> | Other: Enhanced Recovery Pathway (ERP) for Spine<br>* 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.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) |