Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

Study Overview
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Brief Summary
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This study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'Early Recovery After Surgery Clinical Pathway (ERAS CP)' on patient-reported pain levels at the time of discharge following Oblique Lumbar Interbody Fusion (OLIF) surgery

Detailed Description
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Currently, the effectiveness of the ERAS has been widely confirmed in patients undergoing colorectal resection, and it has been verified to reduce length of hospital stay and complications. However, the ERAS protocol for lumbar fusion surgery is based on a few retrospective studies and remains a consensus statement. Recent retrospective studies targeting patients undergoing lumbar fusion surgery reported that implementing ERAS could accelerate post-operative functional recovery and reduce hospital stay. However, there is still a lack of high-quality evidence based on prospective studies. Lumbar fusion surgery is known for potentially leading to severe postoperative pain, which poses challenges in consistently applying ERAS components, such as early ambulation or active oral feeding, after surgery. In light of this, the present study aims to validate the non-inferiority of pain levels at discharge within the ERAS group and to reconfirm the effects of ERAS as observed in retrospective studies. Patients admitted for OLIF will be consecutively screened for eligibility. A computer-generated block randomization will be executed at a 1:1 ratio. In the ERAS group, patients will receive comprehensive education about the treatment process, and a clinical pathway that includes active ambulation and pain control will be protocolized and implemented. Should non-inferiority be demonstrated in both intent-to-treat and per-protocol analyses, non-inferiority will be declared.

Official Title
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A Prospective, Randomized Controlled Trial Comparing the Outcomes of an Enhanced Recovery After Surgery (ERAS) Program With Non-ERAS Care in Patients Undergoing Oblique Lumbar Interbody Fusion (OLIF)

Conditions
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Enhanced Recovery After Surgery, Spinal Fusion, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis

Intervention / Treatment
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* Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1 Capability of independent (or assisted) ambulation for at least 30 minutes with Taking intermittent breaks Enduring any discomfort Voluntary informed consent to participate in the study. Exclusion Criteria: Previous history of lumbar interbody fusion Manual Muscle Testing grade 3 or below Neuropsychiatric disorders such as major depressive disorder Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.) Diagnosis of malignant neoplasm Refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>The experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP) | Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion<br>* In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway<br>|
| No Intervention: Control group<br>The control group will not be implemented with the ERAS CP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale for back pain and leg pain | Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable. | 1 day at discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First ambulation time | The time at which a patient first began ambulation after returning to the ward from the operating room | about postoperative 0 1 day (ex. 4 hours after surgery, 18 hours after surgery) | 
| First self-urination time | The time at which self-voiding was first initiated after the removal of foley catheter | about postoperative 0 1 day (ex. 4 hours after surgery, 18 hours after surgery) | 
| Numeric Rating Scale for back pain and leg pain during inhospital status | Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable. | Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month | 
| Total analgesic consumption | Total dose analgesic used during inhospital status | Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day) | 
| Patient satisfaction scale | We survey patients using a 4-point scale to gauge their overall satisfaction with the treatment process. On this scale, 4 represents 'very satisfied,' 3 is 'satisfied,' 2 is 'dissatisfied,' and 1 indicates 'very dissatisfied. | 1 day at discharge, Postoperative 1-month | 
| Rate of complication related to surgery | We investigate complications related to the surgery. Such complications include vascular damage, ureteral injury, abdominal wall injury, herniation, sympathetic nerve chain damage, leg weakness, and surgical wound infections. | through study completion, an average of 6 month | 
| Rate of medical complication | We examine postoperative internal medicine complications. These complications encompass cardiovascular issues, gastrointestinal disturbances, non-surgical site infections, renal problems, and electrolyte abnormalities. | through study completion, an average of 6 month | 
| 30-day readmission | Any 30-day readmission after surgery | upto postoperative 30 days | 
| medial cost | The total medical cost incurred during the in-hospital stay for the surgery will be calculated | postoperative 1-month | 
| length of hospital stay | length of the hospitalization days | postoperative 1-month |