Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhanced Recovery After Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02949518
Recruitment Status : Completed
First Posted : October 31, 2016
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Enhanced Recovery After Surgery Spine Surgery Other: Enhanced Recovery Pathway (ERP) for Spine Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : May 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
No Intervention: Usual Care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949518


Locations
Layout table for location information
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Layout table for investigator information
Principal Investigator: Ellen Soffin, MD, PhD Hospital for Special Surgery, NY
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
Study Protocol and Statistical Analysis Plan  [PDF] May 4, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02949518    
Other Study ID Numbers: 2016-617
First Posted: October 31, 2016    Key Record Dates
Results First Posted: July 28, 2020
Last Update Posted: July 28, 2020
Last Verified: July 2020