Minimum steroid dose added to incision anesthesia to reduce pain after spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.