Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery

NCT05854043 | Unknown

• 1 other identifier: xuanwuOLIF
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spondylosis; Lumbar Spinal Stenosis; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Postoperative hospital stay

  The length of hospital stay post-operation.

  From the date of surgery to discharge, assessed up to 1 month

Secondary Outcomes (4)

• Postoperative functional recovery

  From the date of surgery to discharge, assessed up to 1 month

• Postoperative pain score

  From the date of surgery to 1 year post-operation

• Postoperative lumbar neurological function assessment

  From the date of surgery to 1 year post-operation

• Postoperative life quality assessment

  From the date of surgery to 1 year post-operation

Study Arms (2)

ERAS group

EXPERIMENTAL

In this group, patients will be treated with modified ERAS protocol.

Other: Modified ERAS protocol

control group

OTHER

In this group, patients will be treated with routine protocol.

Other: routine protocol

Interventions

Modified ERAS protocol OTHER

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.

ERAS group

routine protocol OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu hospital capital medical university

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Spondylosis; Spinal Stenosis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hao Wu, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, MD

CONTACT

17610549095; zhanglei@xwhosp.org

Zhenlei Liu, MD

CONTACT

Zhenlei.liu@xwhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 11, 2023
• Study Start: April 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: April 1, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)