Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis; Lumbar Spondylolisthesis; Spinal Fusion; Enhanced Recovery After Surgery

• Registration Number: NCT05959343
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2023-06-22
• Study Start: 2023-07-12
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-07-25
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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.
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.
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
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
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.
length of hospital stay	postoperative 1-month	length of the hospitalization days

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of