Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery (MERAOLIS)

May 9, 2023 updated by: Xuanwu Hospital, Beijing

Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery: a Randomised Controlled Trial

The goal of this randomized clinical trial is to investigate whether modified enhanced recovery after surgery (ERAS) in oblique lumbar interbody fusion (OLIF) can shorten the postoperative hospital stay among patients with lumbar degenerative disease.

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-80 years old;
  • Lumbar degenerative diseases that meet the indications of fusion surgery;
  • Patients who are suitable for OLIF surgery;
  • Patients who have actually completed OLIF surgery;
  • The number of fusion segments is less than or equal to two;
  • There was no basis for serious diseases of brain, lung, kidney and other important organs, and preoperative American Society of Anesthesiologists (ASA) score was I-III;
  • Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

  • Patients undergoing lumbar fusion surgery due to spinal trauma;
  • Patients undergoing lumbar fusion surgery due to spinal tumor resection;
  • Revision surgery;
  • The number of fused segments is more than 2;
  • Simultaneous lumbar fusion via other approaches, such as transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), etc.;
  • Pregnancy or perinatal period;
  • Blood system diseases lead to coagulation dysfunction;
  • Combined with other diseases, life expectancy less than 2 years;
  • Patients is participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
In this group, patients will be treated with modified ERAS protocol.
Other: Modified ERAS protocol

Modified ERAS protocol for OLIF mainly include perioperative analgesic drug management, operation optimization in the anesthetic management, management of gastrointestinal function, and early mobilization management.

Perioperative analgesic usage:

Nonsteroidal anti-inflammatory drugs (NSAIDs) given when Visual Analogue Scale (VAS)>3. Prehabilitation: Respiratory function exercise; walk at least 200 meters daily. Gastrointestinal function management: Oral lactulose use routinely. Sedation and analgesia: patient status index (PSI) 25-50; analgesia nociception index (ANI) 50-70. Local anesthetic: local infiltration around the psoas muscle. Postop off-bed activity: start mobilization within 24h.
Other: control group
In this group, patients will be treated with routine protocol.
Other: routine protocol
Perioperative analgesic usage: NSAIDs given follow the patients requirement. Prehabilitation: None. Gastrointestinal function management: None. Sedation and analgesia: bispectral index (BIS) 40-60. Local anesthetic: None. Postop off-bed activity: mobilization follow the patients wish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay
Time Frame: From the date of surgery to discharge, assessed up to 1 month
The length of hospital stay post-operation.
From the date of surgery to discharge, assessed up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative functional recovery
Time Frame: From the date of surgery to discharge, assessed up to 1 month
Evaluate the functional recovery through 6 Minutes Walk Distance. A longer walk distance indicates better functional recovery.
From the date of surgery to discharge, assessed up to 1 month
Postoperative pain score
Time Frame: From the date of surgery to 1 year post-operation
Postoperative VAS at different time points for pain assessment. From 0-10, 0 indicates no pain, 10 indicates the most severe pain.
From the date of surgery to 1 year post-operation
Postoperative lumbar neurological function assessment
Time Frame: From the date of surgery to 1 year post-operation
Postoperative Japanese Orthopedics Association (JOA) at different time points for life quality assessment. From 0-29, A lower score indicates more dysfunction.
From the date of surgery to 1 year post-operation
Postoperative life quality assessment
Time Frame: From the date of surgery to 1 year post-operation
Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment.
From the date of surgery to 1 year post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Hao Wu, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xuanwuOLIF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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