Enhanced Recovery After Spine Surgery
- Conditions
- Spine SurgeryEnhanced Recovery After Surgery
- Interventions
- Other: Enhanced Recovery Pathway (ERP) for Spine
- Registration Number
- NCT02949518
- Lead Sponsor
- Hospital for Special Surgery, New York
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Any patient presenting for 1 or 2 level posterior lumbar fusion.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Recovery Pathway for Spine Enhanced Recovery Pathway (ERP) for Spine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to Post-operative Oral Intake. Postoperative Day 1 Measured in hours
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).
Pain Control: Opioid Consumption. 48 hours after surgery Measured in morphine equivalents daily.
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). Postoperative Days 0, 1, and 3 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
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 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
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.
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States