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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway
Seoul National University Hospital
Seoul, Korea, South Korea
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.
Time frame: 1 day at discharge
First ambulation time
The time at which a patient first began ambulation after returning to the ward from the operating room
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1 day at discharge, Postoperative 1-month
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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.
Time frame: 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.
Time frame: through study completion, an average of 6 month
30-day readmission
Any 30-day readmission after surgery
Time frame: upto postoperative 30 days
medial cost
The total medical cost incurred during the in-hospital stay for the surgery will be calculated
Time frame: postoperative 1-month
length of hospital stay
length of the hospitalization days
Time frame: postoperative 1-month