ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.

AZ Nikolaas

Status and phase: Unknown; Phase 4

Conditions: Mobility; Instable Spine; Opioid Use

Treatments: Other: Multimodal, multidisciplinary approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05022745

ERAS for PLIA 2020-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

ERAS group

Experimental group

Description:

Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care.

Treatment:

Other: Multimodal, multidisciplinary approach

Standard group

Active Comparator group

Description:

Posterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative

Treatment:

Other: Multimodal, multidisciplinary approach