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Completed

NCT Number: NCT02949518

Enhanced Recovery After Spine Surgery

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.

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Key information

Conditions

Enhanced Recovery After Surgery Spine Surgery

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced Recovery Pathway (ERP) for Spine

Other

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.

Primary outcomes

  1. Patient Score on QoR40 Inventory.

    Time frame: Postoperative Day 3

    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).

Secondary outcomes

  1. Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.

    Time frame: Postoperative Day 5

    Measured in days after surgery (in half-day increments).

  2. Pain Control: Opioid Consumption.

    Time frame: 48 hours after surgery

    Measured in morphine equivalents daily.

  3. Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1

    Time frame: Postoperative Day 1

    Scale of 0-10, 0 being no pain, 10 being the worst pain possible

  4. Time to Post-operative Oral Intake.

    Time frame: Postoperative Day 1

    Measured in hours

  5. Number of Participants With Post-operative Nausea, Vomiting and Ileus

    Time frame: Postoperative Day 5

    If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge

  6. Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).

    Time frame: Postoperative Days 0, 1, and 3

  7. Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).

    Time frame: Postoperative Days 0, 1, and 3

  8. Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).

    Time frame: Postoperative Days 0, 1, and 3

  9. Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).

    Time frame: Postoperative Days 0, 1, and 3

  10. Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE

    Time frame: Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)

    Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2016
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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