Enhanced Recovery After Surgery in Orthopaedic Spine Surgery (ERAS)

University of California (UC) Davis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lumbar Surgery

Treatments: Drug: All oral administration group; Drug: Intravenous Infusion group

Study type: Interventional

Funder types: Other

Identifiers

NCT04562610

1586560

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Group A: All oral pre-operative analgesics

Active Comparator group

Description:

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

Treatment:

Drug: All oral administration group

Group B: Intravenous agents

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Infusion group