NCT02949518|CompletedResults
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Sponsor study identifier
interventional
56
1 country
1
Study Start
November 28, 2016
Actual (reported)Primary Completion
February 2020
Actual (reported)Study Completion
May 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2016
Actual (reported)October 31, 2016
Actual (reported)November 28, 2016
Actual (reported)February 2020
Actual (reported)May 2020
Actual (reported)July 28, 2020
Actual (reported)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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital for Special Surgery
New York, New York, 10021, United States
Ellen Soffin, MD, PhD
Hospital for Special Surgery, NY
56 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2016
First Posted
October 31, 2016
Study Start
November 28, 2016
Actual (reported)Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
Contact the study team to confirm eligibility.
Primary Completion
February 2020
Actual (reported)Study Completion
May 2020
Actual (reported)Last Updated
July 28, 2020
Results First Posted
July 28, 2020
Record last verified: 2020-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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