Enhanced Recovery After Surgery, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Spinal Fusion
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALEnhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion
In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway
Sponsors
Medical Research Collaborating Center, Seoul, Korea
Armed Forces Capital Hospital, Republic of Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1 2. Capability of independent (or assisted) ambulation for at least 30 minutes with 1. Taking intermittent breaks 2. Enduring any discomfort 3. Voluntary informed consent to participate in the study.
Exclusion criteria
1. Previous history of lumbar interbody fusion 2. Manual Muscle Testing grade 3 or below 3. Neuropsychiatric disorders such as major depressive disorder 4. Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.) 5. Diagnosis of malignant neoplasm 6. Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale for back pain and leg pain | 1 day at discharge | Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First self-urination time | about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery) | The time at which self-voiding was first initiated after the removal of foley catheter |
| Numeric Rating Scale for back pain and leg pain during inhospital status | Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month | Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable. |
| Total analgesic consumption | Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day) | Total dose analgesic used during inhospital status |
| Patient satisfaction scale | 1 day at discharge, Postoperative 1-month | 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. |
| First ambulation time | about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery) | The time at which a patient first began ambulation after returning to the ward from the operating room |
| Rate of medical complication | through study completion, an average of 6 month | We examine postoperative internal medicine complications. These complications encompass cardiovascular issues, gastrointestinal disturbances, non-surgical site infections, renal problems, and electrolyte abnormalities. |
| 30-day readmission | upto postoperative 30 days | Any 30-day readmission after surgery |
| medial cost | postoperative 1-month | The total medical cost incurred during the in-hospital stay for the surgery will be calculated |
| length of hospital stay | postoperative 1-month | length of the hospitalization days |
| Rate of complication related to surgery | through study completion, an average of 6 month | 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. |
Countries
South Korea
Outcome results
None listed