Clinical trial NCT02949518: Enhanced Recovery After Spine Surgery
Official title: Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced Recovery After Surgery
Spine Surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Patient Score on QoR40 Inventory.
timeFrame: Postoperative Day 3
Secondary outcomes:
measure: Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.
timeFrame: Postoperative Day 5
measure: Pain Control: Opioid Consumption.
timeFrame: 48 hours after surgery
measure: Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1
timeFrame: Postoperative Day 1
measure: Time to Post-operative Oral Intake.
timeFrame: Postoperative Day 1
measure: Number of Participants With Post-operative Nausea, Vomiting and Ileus
timeFrame: Postoperative Day 5
measure: Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
timeFrame: Postoperative Days 0, 1, and 3
measure: Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
timeFrame: Postoperative Days 0, 1, and 3
measure: Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
timeFrame: Postoperative Days 0, 1, and 3
measure: Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
timeFrame: Postoperative Days 0, 1, and 3
measure: Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE
timeFrame: Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, NY
name: Ellen Soffin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: