ERAS Protocol for Single-level Posterior Lumbar Arthrodesis; a Randomized Prospective Study
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- AZ Nikolaas
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Length of hospital stay
Study Overview
Brief Summary
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.
Detailed Description
Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The interventions described in the patient information brochure make masking impossible
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent
Exclusion Criteria
- •Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).
- •Known kidney insufficiency: GFR <30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: 2-3 days + 11 days
Number of days hospitalization
Secondary Outcomes
- Pain intensity(day of discharge)
- 11-days readmission rate(discharge + 11 days)
- Analgesic use, including opioids(2-3)
Investigators
Erik Van de Kelft, M.D., PhD
Head of neurosurgery department
AZ Nikolaas