Clinical trial NCT05959343: Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced Recovery After Surgery
Spinal Fusion
Lumbar Spinal Stenosis
Lumbar Spondylolisthesis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Collaborating Center, Seoul, Korea
name: Armed Forces Capital Hospital, Republic of Korea
First posted: 2023-07-25
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale for back pain and leg pain
timeFrame: 1 day at discharge
Secondary outcomes:
measure: First ambulation time
timeFrame: about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
measure: First self-urination time
timeFrame: about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
measure: Numeric Rating Scale for back pain and leg pain during inhospital status
timeFrame: Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month
measure: Total analgesic consumption
timeFrame: Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day)
measure: Patient satisfaction scale
timeFrame: 1 day at discharge, Postoperative 1-month
measure: Rate of complication related to surgery
timeFrame: through study completion, an average of 6 month
measure: Rate of medical complication
timeFrame: through study completion, an average of 6 month
measure: 30-day readmission
timeFrame: upto postoperative 30 days
measure: medial cost
timeFrame: postoperative 1-month
measure: length of hospital stay
timeFrame: postoperative 1-month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
Study officials:
affiliation: Seoul National University Hospital
name: Chi Heon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.