N/A
Completed N=56
Enhanced Recovery After Spine Surgery
Enhanced Recovery After Surgery · spine surgery
Source: ClinicalTrials.gov NCT02949518 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Patient Score on QoR40 Inventory. — 179.4; 170.3 scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Score on QoR40 Inventory. |
179.4; 170.3 | — |
| SECONDARY Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. |
2.8; 3.1; 1.4; 1.9 | — |
| SECONDARY Pain Control: Opioid Consumption. |
61.8; 133.2; 30; 75 | — |
| SECONDARY Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1 |
3; 4 | — |
| SECONDARY Time to Post-operative Oral Intake. |
5.1; 7.9 | — |
| SECONDARY Number of Participants With Post-operative Nausea, Vomiting and Ileus |
8; 13; 3; 2; 4; 6 | — |
| SECONDARY Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). |
2.5; 2.5; 5; 5; 8; 8 | — |
| SECONDARY Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). |
6.3; 5.4; 0.5; 0.5; 8.3; 8.9 | — |
| SECONDARY Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). |
0.4; 0.4; 1.6; 1.6; 6.1; 15.9 | — |
| SECONDARY Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). |
8; 10; 15; 14; 18; 15.5 | — |
| SECONDARY Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE |
1; 2; 1; 0; 1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02949518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.