Enhanced Recovery After Spine Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery; Enhanced Recovery After Surgery
• Intervention / Treatment: Other: Enhanced Recovery Pathway (ERP) for Spine

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Enhanced Recovery Pathway for Spine	Other: Enhanced 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Ellen Soffin, MD, PhD, Hospital for Special Surgery, NY

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-617