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Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery

NCT05854043 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-05-11

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Hao Wu, MD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-08-01
Completion
2025-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05854043 on ClinicalTrials.gov