Enhanced Recovery After Spine Surgery

Enhanced Recovery After Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949518
• Other study ID #: 2016-617
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: May 2020

Study information

• Verified date: July 2020
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Spine Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pain Control: Opioid Consumption.	Measured in morphine equivalents daily.	48 hours after surgery
Secondary	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
Secondary	Time to Post-operative Oral Intake.	Measured in hours	Postoperative Day 1
Secondary	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
Secondary	Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).		Postoperative Days 0, 1, and 3
Secondary	Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).		Postoperative Days 0, 1, and 3
Secondary	Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).		Postoperative Days 0, 1, and 3
Secondary	Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).		Postoperative Days 0, 1, and 3
Secondary	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)