Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

Lumbar Spinal Stenosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959343
• Other study ID #: H-2305-085-1423
• Status: Completed
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Spinal Fusion
• Spinal Stenosis
• Spondylolisthesis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Korea

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Armed Forces Capital Hospital, Republic of Korea, Medical Research Collaborating Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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):39 — View 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 observati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day at discharge
Secondary	First ambulation time	The time at which a patient first began ambulation after returning to the ward from the operating room	about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
Secondary	First self-urination time	The time at which self-voiding was first initiated after the removal of foley catheter	about postoperative 0~1 day (ex. 4 hours after surgery, 18 hours after surgery)
Secondary	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.	Daily measurement through the hospitalization period for surgery(ex. at postoperative 1day, at postoperative 2day), Postoperative 1-month
Secondary	Total analgesic consumption	Total dose analgesic used during inhospital status	Daily measurement through the hospitalization period for surgery(ex. at postoperative 1 day, at postoperative 3 day)
Secondary	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.	1 day at discharge, Postoperative 1-month
Secondary	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.	through study completion, an average of 6 month
Secondary	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.	through study completion, an average of 6 month
Secondary	30-day readmission	Any 30-day readmission after surgery	upto postoperative 30 days
Secondary	medial cost	The total medical cost incurred during the in-hospital stay for the surgery will be calculated	postoperative 1-month
Secondary	length of hospital stay	length of the hospitalization days	postoperative 1-month