Clinical trial NCT04562610: Enhanced Recovery After Surgery in Orthopaedic Spine Surgery
Official title: A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lumbar Surgery
Keywords: lumbar decompression and fusions 1 to 3 levels
lumbar decompression and fusions
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators are comparing the efficacy of commonly administered pre-emptive analgesic medications administered in a randomized fashion in parallel. In one group all medications will be administered by mouth and in one group two of the medications will be administered via the intravenous route.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Operative blood loss (ml)
timeFrame: From incision start to wound closed. 0-6 hours after operation start.
measure: Postoperative pain scores (VAS) Visual analog scale.
timeFrame: 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
measure: Immediate postoperative opiate analgesic requirement
timeFrame: 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)
measure: Time from post-anesthesia care unit (PACU) admission to discharge
timeFrame: PACU admission to PACU discharge (range 0-6 hours)
measure: blood transfusion requirement
timeFrame: At any time point during hospitalization. ( 0-48 hours after operation)
measure: Length of hospital stay
timeFrame: From day of operation (day zero) through hospital discharge.Expected range 1-3 days)
Secondary outcomes:
measure: Overall cost of hospitalization.
timeFrame: Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.
measure: Post operative complications
timeFrame: From initiation of operation to hospital discharge (Day1-3)
measure: Oswestry Disability Index (ODI)
timeFrame: The investigators will measure change between baseline (ODI) and at surgical visits and 12 months after operation.
measure: Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)
timeFrame: The investigators will measure change between PROMIS CAT scores between between baseline and 12 months after operation.
measure: University of California, Davis Short Form 20 (UCD SF-20)
timeFrame: The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: Univeristy of California Davis Medical Center
name: Rolando F Roberto, MD
role: PRINCIPAL_INVESTIGATOR
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