Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery

NCT ID: NCT05854043

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-04-01

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.

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.

Conditions

Lumbar Spondylosis; Lumbar Spinal Stenosis; Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ERAS group

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

Group Type: EXPERIMENTAL

Modified ERAS protocol

Intervention Type: 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.

control group

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

Group Type: OTHER

routine protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu hospital capital medical university

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Zhang, MD

Role: CONTACT

zhanglei@xwhosp.org

17610549095

Zhenlei Liu, MD

Role: CONTACT

Zhenlei.liu@xwhosp.org

Facility Contacts

Lei Zhang, MD

Role: primary

zhanglei@xwhosp.org

17510549095

Other Identifiers

xuanwuOLIF

Identifier Type: -

Identifier Source: org_study_id