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Completed

NCT Number: NCT04562610

Enhanced Recovery After Surgery in Orthopaedic Spine Surgery

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.

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Key information

Conditions

Lumbar Surgery

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Infusion group

Drug

The intravenous infusion group will receive two medications via the intravenous infusion route. These medications are Ofirmev ( acetaminophen ) 1,000mg and tranexamic acid 2,000 mg , an antifibrinolytic drug. In addition to these drugs, study subjects will receive Celecoxib 200mg by mouth and Gabapentin 600 mg by mouth prior to operation.

All oral administration group

Drug

Subjects in the oral administration group will receive the following pre-emptive analgesic drugs, acetaminophen 1,000mg, Celecoxib 200mg and gabapentin 600mg via the oral route prior to operation. In addition they will receive the antifibrinolytic drug, tranexamic acid 2,000mg via an oral route as well prior to operation.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Overall cost of hospitalization.

    Time frame: Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.

    Total cost of hospitalization including hospital stay, pharmacy charges, and other professional fees.

  2. Post operative complications

    Time frame: From initiation of operation to hospital discharge (Day1-3)

    This outcome will be binary (yes/no). The investigators will record the occurrence of any operative or postoperative complications from hospital admission to hospital discharge. If no complications occur these will be recorded as zero; should complications occur during hospitalization, these complication will be recorded (readmission rate, infection, wound dehiscence, return to OR, deep vein thrombosis/pulmonary embolism (DVT/PE). Intra-operative complications, postoperative complications, including but not limited to respiratory events, GI complications including ileus, postoperative nausea and vomiting, ground level falls, orthostatic hypotensive events or any complication associated with early mobilization. The number of complications will be listed in addition to the individual complication type.

  3. Oswestry Disability Index (ODI)

    Time frame: The investigators will measure change between baseline (ODI) and at surgical visits and 12 months after operation.

    10 question survey instrument with domains which include pain, physical, and social function. The range of scores is from 0-100 with 0 being no disability and 100 representing bedbound patients with no capacity to function in any domain.

  4. Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)

    Time frame: The investigators will measure change between PROMIS CAT scores between between baseline and 12 months after operation.

    NIH computer adapted technology patient reported outcomes measures of pain interference, physical function, depression, anxiety, and upper extremity function.

  5. University of California, Davis Short Form 20 (UCD SF-20)

    Time frame: The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation

    Patient reported outcome instrument with 20 questions and score between range 0- 100 points. Domains surveyed include self perception of health, bodily pain, social function, physical function and role emotional health.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications

Acronym: ERAS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2020
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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