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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Enhanced Recovery After Surgery
- Sponsor
- Seoul National University Hospital
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale for back pain and leg pain
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Chi Heon Kim
Professor
Seoul National University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Numeric Rating Scale for back pain and leg pain
Time Frame: 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 Outcomes
- First ambulation time(about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery))
- Total analgesic consumption(Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day))
- Patient satisfaction scale(1 day at discharge, Postoperative 1-month)
- Rate of medical complication(through study completion, an average of 6 month)
- 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)
- 30-day readmission(upto postoperative 30 days)
- medial cost(postoperative 1-month)
- First self-urination time(about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery))
- Rate of complication related to surgery(through study completion, an average of 6 month)
- length of hospital stay(postoperative 1-month)