NCT02949518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

November 28, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 28, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

October 7, 2016

Results QC Date

June 4, 2020

Last Update Submit

July 27, 2020

Conditions

Enhanced Recovery After SurgerySpine Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

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

    Postoperative Day 5

  • Pain Control: Opioid Consumption.

    48 hours after surgery

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

    Postoperative Day 1

  • Time to Post-operative Oral Intake.

    Postoperative Day 1

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

    Postoperative Day 5

  • +5 more secondary outcomes

Study Arms (2)

Enhanced Recovery Pathway for Spine

EXPERIMENTAL
Other: Enhanced Recovery Pathway (ERP) for Spine

Usual Care

NO INTERVENTION

Interventions

Enhanced Recovery Pathway (ERP) for SpineOTHER

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.

Enhanced Recovery Pathway for Spine

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient presenting for 1 or 2 level posterior lumbar fusion.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Results Point of Contact

Title
Dr. Ellen Soffin
Organization
Hospital for Special Surgery
soffine@hss.edu
212-606-1206

Study Officials

  • Ellen Soffin, MD, PhD

    Hospital for Special Surgery, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 31, 2016

Study Start

November 28, 2016

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

July 28, 2020

Results First Posted

July 28, 2020

Record last verified: 2020-07

Locations

US(1)