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Completed

NCT Number: NCT05959343

Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

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

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Key information

Conditions

Enhanced Recovery After Surgery Bone Diseases Lumbar Spinal Stenosis Lumbar Spondylolisthesis Musculoskeletal Diseases Spinal Diseases Spinal Fusion Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Recovery After Surgery program for Oblique Lumbar Interbody Fusion

Behavioral

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

Primary outcomes

  1. Numeric Rating Scale for back pain and leg pain

    Time frame: 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 outcomes

  1. First ambulation time

    Time frame: 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

  2. First self-urination time

    Time frame: 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

  3. Numeric Rating Scale for back pain and leg pain during inhospital status

    Time frame: 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.

  4. Total analgesic consumption

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

    Total dose analgesic used during inhospital status

  5. Patient satisfaction scale

    Time frame: 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.

  6. Rate of complication related to surgery

    Time frame: 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.

  7. Rate of medical complication

    Time frame: 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.

  8. 30-day readmission

    Time frame: upto postoperative 30 days

    Any 30-day readmission after surgery

  9. medial cost

    Time frame: postoperative 1-month

    The total medical cost incurred during the in-hospital stay for the surgery will be calculated

  10. length of hospital stay

    Time frame: postoperative 1-month

    length of the hospitalization days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2023
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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