Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

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)

Medical Research Collaborating Center, Seoul, Korea, Armed Forces Capital Hospital, Republic of Korea

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.

In the ERAS CP group, the components of the ERAS are protocolized and implemented as a clinical pathway

Pain intensity will be recorded on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the maximum pain imaginable.

The time at which a patient first began ambulation after returning to the ward from the operating room

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

Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day)

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.

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.

We examine postoperative internal medicine complications. These complications encompass cardiovascular issues, gastrointestinal disturbances, non-surgical site infections, renal problems, and electrolyte abnormalities.

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

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.

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.

Porche K, Yan S, Mohamed B, Garvan C, Samra R, Melnick K, Vaziri S, Seubert C, Decker M, Polifka A, Hoh DJ. Enhanced recovery after surgery (ERAS) improves return of physiological function in frail patients undergoing one- to two-level TLIFs: an observational retrospective cohort study. Spine J. 2022 Sep;22(9):1513-1522. doi: 10.1016/j.spinee.2022.04.007. Epub 2022 Apr 18.

Porche K, Samra R, Melnick K, Brennan M, Vaziri S, Seubert C, Polifka A, Hoh DJ, Mohamed B. Enhanced recovery after surgery (ERAS) for open transforaminal lumbar interbody fusion: a retrospective propensity-matched cohort study. Spine J. 2022 Mar;22(3):399-410. doi: 10.1016/j.spinee.2021.10.007. Epub 2021 Oct 21.