Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ERAS group The experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP) |
Behavioral: Enhanced 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
|
| No Intervention: Control group The control group will not be implemented with the ERAS CP |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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.
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1
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Capability of independent (or assisted) ambulation for at least 30 minutes with
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Taking intermittent breaks
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Enduring any discomfort
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Voluntary informed consent to participate in the study.
Exclusion Criteria:
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Previous history of lumbar interbody fusion
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Manual Muscle Testing grade 3 or below
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Neuropsychiatric disorders such as major depressive disorder
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Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.)
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Diagnosis of malignant neoplasm
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Refusal to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea | Korea, Republic of | 03080 |
Sponsors and Collaborators
- Seoul National University Hospital
- Medical Research Collaborating Center, Seoul, Korea
- Armed Forces Capital Hospital, Republic of Korea
Investigators
- Principal Investigator: Chi Heon Kim, MD, PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Debono B, Wainwright TW, Wang MY, Sigmundsson FG, Yang MMH, Smid-Nanninga H, Bonnal A, Le Huec JC, Fawcett WJ, Ljungqvist O, Lonjon G, de Boer HD. Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Spine J. 2021 May;21(5):729-752. doi: 10.1016/j.spinee.2021.01.001. Epub 2021 Jan 12.
- Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- H-2305-085-1423