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Enhanced Recovery Medication Strategies for Lumbar Surgery (ERAS Trial)
Phase 2 & 3
Waitlist Available
Led By Rolando F Roberto, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgery scheduled for lumbar decompression and fusions 1 to 3 levels
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the investigators will measure change between baseline/pre-surgical vas score to immediate post surgical vas, and at 4 hour intervals until hospital discharge. 0-48 hours
Awards & highlights
ERAS Trial Summary
This trial will compare the outcomes of two groups of patients who will receive different types of medication before surgery.
Who is the study for?
This trial is for individuals scheduled for 1 to 3 level lumbar decompression and fusion surgeries. It's not suitable for cancer-related procedures, those who can't move around soon after surgery, spine trauma patients, or anyone with a history of blood clots or heart attacks that make it unsafe to use tranexamic acid.Check my eligibility
What is being tested?
The study compares the effects of two preoperative medication methods on recovery after elective spine surgery: one group receives medications through an IV and the other takes them orally. The focus is on how these approaches affect rehabilitation and costs.See study design
What are the potential side effects?
Potential side effects are not specified in the provided information but may include typical risks associated with anesthesia, surgical procedures, and reactions to specific medications like tranexamic acid.
ERAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a surgery to relieve pressure in my lower back involving 1 to 3 spinal levels.
ERAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the investigators will measure change between baseline/pre-surgical vas score to immediate post surgical vas, and at 4 hour intervals until hospital discharge. 0-48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the investigators will measure change between baseline/pre-surgical vas score to immediate post surgical vas, and at 4 hour intervals until hospital discharge. 0-48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immediate postoperative opiate analgesic requirement
Length of hospital stay
Operative blood loss (ml)
+3 moreSecondary outcome measures
Oswestry Disability Index (ODI)
Overall cost of hospitalization.
Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)
+2 moreERAS Trial Design
2Treatment groups
Active Control
Group I: Group A: All oral pre-operative analgesicsActive Control1 Intervention
Group A patients will be administered the following medications in the preoperative holding area:
Acetaminophen 1,000 mg by mouth prior to operation
Celecoxib 200mg by mouth prior to operation
Tranexamic acid 2 grams by mouth prior to operation
Gabapentin 600mg by mouth prior to operation
Group II: Group B: Intravenous agentsActive Control1 Intervention
Group B patients will receive:
Acetaminophen (Ofirmev) 1,000mg intravenous prior to operation
Celecoxib 200mg by mouth prior to operation
Tranexamic acid 2grams intravenous at start of operation
Gabapentin 600 mg by mouth prior to operation
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,841 Total Patients Enrolled
Rolando F Roberto, MDPrincipal InvestigatorUniveristy of California Davis Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take tranexamic acid due to a history of blood clots or heart issues.I have health issues that prevent me from moving around soon after surgery.I am scheduled for a surgery to relieve pressure in my lower back involving 1 to 3 spinal levels.I have undergone cancer-related surgeries.I have had an injury to my neck, upper back, or lower back.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: All oral pre-operative analgesics
- Group 2: Group B: Intravenous agents
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I be a candidate for participation in this research?
"Lumbar region patients that are between 18-105 years old can be accepted into this trial. Around 150 people will be admitted into the study."
Answered by AI
Are patient volunteers still being accepted for this research program?
"This trial, which was initially advertised on November 18th 2020, is still recruiting patients as of February 1st, 2022 according to the listing on clinicaltrials.gov."
Answered by AI
What is the aim of this research?
"The aim of this study is to assess the efficacy of blood transfusions in From incision start to wound closed. 0-6 hours after operation start. patients. Additionally, the trial will collect data on the Oswestry Disability Index (ODI), the University of California, Davis Short Form 20 (UCD SF-20), and the Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)."
Answered by AI
Would someone in their mid-80s still be able to join this trial?
"This trial is only taking individuals between the ages of 18 and 105 in order to adhere to the study's inclusion criteria."
Answered by AI
How many total individuals are testing this medication in this clinical trial?
"That is accurate. The information available on clinicaltrials.gov reveals that this particular trial is still recruiting patients. This trial was initially posted on November 18th, 2020 and was most recently updated on February 1st, 2022. The researchers conducting this study need to enroll a total of 150 patients from 1 location."
Answered by AI
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