Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

Seoul National University

Status: Completed

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

Treatments: Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05959343

H-2305-085-1423

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

ERAS group

Experimental group

Description:

The experimental group will be implemented with the ERAS Clinical Pathway (ERAS CP)

Treatment:

Behavioral: Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion

Control group

No Intervention group

Description:

The control group will not be implemented with the ERAS CP