Minimum steroid dose added to incision anesthesia to reduce pain after spine surgery
Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial
This trial tests whether adding different low doses of betamethasone to ropivacaine injected into the incision reduces pain after spine surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 535 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06785350 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–65 undergoing cervical, thoracic, or lumbar spine surgery (up to three levels) at Beijing Tiantan Hospital will receive local infiltration of the surgical incision with one of five regimens: 0.5% ropivacaine alone or ropivacaine combined with betamethasone (Diprospan) at 0.012%, 0.009%, 0.006%, or 0.003%. The study compares postoperative incisional pain and related outcomes to identify the minimum effective concentration of betamethasone when used with local anesthetic. Standard perioperative care is provided and patients with significant comorbidities or contraindications are excluded. Results aim to guide dosing to minimize pain and opioid requirements after spine surgery.
Who should consider this trial
Good fit: Adults 18–65 years old with ASA physical status I–II scheduled for cervical, thoracic, or lumbar spine surgery of up to three levels who can give informed consent are the intended participants.
Not a fit: Patients with prior spinal surgery, peri-incisional infection, diabetes or other metabolic disorders, significant liver or kidney dysfunction, current systemic steroid use, pregnancy or breastfeeding, extreme BMI, serious neurologic or psychiatric disease, or substance abuse are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, patients could have less incision pain after spine surgery, shorter recovery, and lower opioid use.
How similar studies have performed: Previous reports of local infiltration combining anti-inflammatory drugs with local anesthetic have reduced postoperative pain, but the optimal steroid concentration for spinal incision infiltration remains unestablished.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level). Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II. Exclusion Criteria: Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\<15kg/m2 or\>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \< 15 before surgery. Unable to provide written informed consent. Withdrawal criteria: Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up. Reoperation during follow-up.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.