Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Spondylosis
Conditions
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.
Interventions
OTHERModified 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.
OTHERroutine 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
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hospital stay | From the date of surgery to discharge, assessed up to 1 month | The length of hospital stay post-operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative functional recovery | 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. |
| Postoperative pain score | 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. |
| Postoperative lumbar neurological function assessment | 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. |
| Postoperative life quality assessment | From the date of surgery to 1 year post-operation | Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment. |
Countries
China
Contacts
Primary ContactLei Zhang, MD
Backup ContactZhenlei Liu, MD
Outcome results
None listed