Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery

Lumbar Spinal Stenosis Clinical Trial

— MERAOLIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854043
• Other study ID #: xuanwuOLIF
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Lei Zhang, MD
• Phone: 17610549095
• Email: zhanglei[@]xwhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: April 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Lumbar Spondylosis
• Spinal Stenosis
• Spondylosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xuanwu hospital capital medical university	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hospital stay	The length of hospital stay post-operation.	From the date of surgery to discharge, assessed up to 1 month
Secondary	Postoperative functional recovery	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
Secondary	Postoperative pain score	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
Secondary	Postoperative lumbar neurological function assessment	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
Secondary	Postoperative life quality assessment	Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment.	From the date of surgery to 1 year post-operation