NCT06785350 Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery
| NCT ID | NCT06785350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Pain Management |
| Study Type | INTERVENTIONAL |
| Enrollment | 535 participants |
| Start Date | 2025-01-25 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 535 participants in total. It began in 2025-01-25 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06785350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Pain Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785350 currently recruiting?
Yes, NCT06785350 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Tiantan Hospital to inquire about joining.
Where is the NCT06785350 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06785350 clinical trial?
NCT06785350 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 535 participants.