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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02949518
Other study ID # 2016-617
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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