A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications
Overview
- Phase
- Phase 2
- Intervention
- All oral administration group
- Conditions
- Lumbar Surgery
- Sponsor
- University of California, Davis
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This study aims to determine the impact and effect of enhanced recovery after surgery (ERAS) principles in the recovery and rehabilitation of patients following elective orthopaedic spine surgery with a specific emphasis on oral versus intravenous preoperative medication administration and the resultant cost differences.
Detailed Description
In orthopaedic surgery, ERAS programs have profoundly impacted outcomes in hip and knee replacement surgery.4 Large, prospective studies have demonstrated a reduction in mortality rate, median length of stay, and blood transfusion rates with no change in re-admission rates.5,6 However, there is a paucity of data evaluating the application of ERAS principles in other orthopaedic subspecialties, especially elective spine surgery. With over 35,000 cervical spine procedures performed in 2011, almost 200,000 elective lumbar fusion surgeries performed in 2015, and 83.7 million people estimated to be ≥ 65 years old in 2050, the demand for elective spine surgery is high and will continue to grow placing a significant economic burden on the health care system.This increasing demand in conjunction with prolonged hospital stays, extensive postoperative pain regimens, and the advent of minimally invasive procedures provides a compelling argument for the suitability of ERAS protocols in elective spine surgery. While distinct components of the ERAS pathway have been investigated in spine surgery including preoperative education, multimodal pain management, surgical approach, nutrition, and physical therapy, few studies have investigated the collective application of these interventions. Furthermore, these studies have been retrospective in nature, limiting their generalizability.The goal of this study is to perform a prospective, randomized trial to evaluate the efficacy and cost-effectiveness of oral versus intravenous medications preoperatively. The investigators also plan to evaluate the effect of the implementation of the standard of care ERAS principles on the outcome of patients undergoing elective spine surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Surgery scheduled for lumbar decompression and fusions 1 to 3 levels
Exclusion Criteria
- •Cervical, thoracic, or lumbar trauma
- •Oncologic procedures
- •Patient's with comorbidities preventing early postoperative mobilization
- •Patients with contraindications to tranexamic acid (TXA) administration including but not limited to patients with a history of thromboembolic or ischemic events (PE, DVT, CVA, MI). Additional contraindications are decided by treating orthopaedic surgeon
Arms & Interventions
Group A: All oral pre-operative analgesics
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
Intervention: All oral administration group
Group B: Intravenous agents
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
Intervention: Intravenous Infusion group
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: From day of operation (day zero) through hospital discharge.Expected range 1-3 days)
Length of hospital stay (LOS) in days with a range from 1-6 days.
Postoperative pain scores (VAS) Visual analog scale.
Time Frame: 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
Visual analog pain score from 1-10 points reported by patient with 10 severe pain and 0 being no pain. The investigators are comparing the efficacy of two different analgesia regimens, this is a critical primary outcome measure.
blood transfusion requirement
Time Frame: At any time point during hospitalization. ( 0-48 hours after operation)
Amount of blood transfused expressed in milliliters (ml). As this may range from binary ( yes or no ) and could also be recorded in volume milliliters; the owill record and report both.
Immediate postoperative opiate analgesic requirement
Time Frame: From post anesthesia care unit admission until hospital discharge. As the investigators are measuring the 24 hour Morphine equivalent dosing from anesthesia emergence until hospital discharge. ( 0-48 hours after operation)
Immediate post procedure Opiate analgesic requirement measured in Morphine equivalents (mg)
Operative blood loss (ml)
Time Frame: From incision start to wound closed. 0-6 hours after operation start.
Actual or estimated blood loss during operation. This is typically included in the surgeons operative note.
Time from post-anesthesia care unit (PACU) admission to discharge
Time Frame: PACU admission to PACU discharge (range 0-6 hours)
This is the time from anesthesia emergence to initiation of meaningful activity. and recovery measured from anesthetic (in hours) with a range of 1-12 hours.
Secondary Outcomes
- Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)(The investigators will measure change between PROMIS CAT scores between between baseline and 12 months after operation.)
- Oswestry Disability Index (ODI)(The investigators will measure change between baseline (ODI) and at surgical visits and 12 months after operation.)
- University of California, Davis Short Form 20 (UCD SF-20)(The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation)
- Post operative complications(From initiation of operation to hospital discharge (Day1-3))
- Overall cost of hospitalization.(Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.)