Enhanced Recovery After Spine Surgery Randomized Clinical Trial

NCT05830331 | Completed

• 1 other identifier: 831303
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two different approaches to the care patients receive before, during and after their spinal surgery and to determine if either approach has a significant difference in patient outcomes, opioid use, and recovery following spine surgery. The study will compare the standard-of-care surgical approach taken at the Hospital of the University of Pennsylvania with the Enhanced Recovery After Spine Surgery (ERASS) pathway. ERASS is a program that will provide additional education before your surgery, reduce your opioid consumption, and provide earlier physical therapy than you would normally receive under the standard-of-care approach, among other protocols outlined in this consent. Patients will be randomized to receive either of these approaches and the researchers will collect information to better understand if the ERASS approach provides more patient benefits.

Conditions

ERAS

Outcome Measures

Primary Outcomes (2)

• Opioid use during hospitalization

  Total opioid use during hospitalization after surgery

  post-operative days during hospital admission, up to 20 days

• Opioid use after surgery

  Proportion of patients using opioids one month after surgery

  up to one month after surgery

Secondary Outcomes (36)

• Total Opioid Consumption During Hospitalization Using Morphine Equivalents

  post-operative days during hospital admission, up to 20 days

• Usage of PCA during hospitalization

  from admission to discharge, up to 20 days

• Opioid Consumption During Hospitalization

  post-operative days during hospital admission, up to 20 days

• Opioid Refills After Surgery

  up to one month after surgery

• Opioid Prescribed After Surgery

  up to one month after surgery

Study Arms (2)

Control

NO INTERVENTION

Treatment

EXPERIMENTAL

Other: ERASS Pathway

Interventions

ERASS Pathway OTHER

Enhanced Recovery After Spinal Surgery

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 and older (both male and female), who present to the department of neurosurgery at the Hospital of the University of Pennsylvania and who are determined to require elective spine surgery with one of two senior spine neurosurgeons, Drs. Malhotra and Marcotte.

You may not qualify if:

• Patients who are pregnant
• Incarceration
• Patients under the age of 18
• Patients unable to participate in the consent procedure
• Patients undergoing emergent surgery
• Patients with liver disease

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19102, United States

Location

Study Officials

• Zarina Ali, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Neil Malhotra, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Penn Presbyterian Medical Center Department of Neurosurgery

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 26, 2023
• Study Start: February 18, 2019
• Primary Completion: November 13, 2020
• Study Completion: October 13, 2021
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)