Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2025-07-16
535
Participants Needed
1
Research Sites
13 weeks
Total Duration
Postoperative pain at the site of a surgical incision is a common issue after spine surgery and can lead to slower recovery, longer hospital stays, and increased risk of complications. Researchers are studying the best concentration of anti-inflammatory drugs combined with pain relievers for local injection around spinal surgical incisions to reduce this pain. This randomized controlled trial aims to find the minimum effective dose of betamethasone, an anti-inflammatory steroid, combined with ropivacaine, a local anesthetic, to prevent pain after spinal surgery. Participants will receive one of five different local infiltration treatments before the incision: four groups will receive varying concentrations of betamethasone combined with 0.5% ropivacaine, while a control group receives only 0.5% ropivacaine. Standard general anesthesia with drugs like sufentanil and propofol will be given during surgery. After surgery, patients will use a patient-controlled analgesia (PCA) pump delivering sufentanil and ondansetron to manage pain and nausea. The study will track the use of this pump, additional pain medications, and other parameters for up to 3 months. During the study, participants will be assessed on their pain levels using visual scales at multiple times up to 3 months post-surgery. Researchers will also measure opioid consumption, sedation levels, nausea, satisfaction, quality of life, disability, scar appearance, and any side effects. The main outcome is the amount of sufentanil used via PCA within 48 hours after surgery. Close monitoring of medication use and intraoperative details will continue throughout the study to evaluate the pain prevention effect of the local infiltration solutions.
CONDITIONS
Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and 48 hours postoperatively
Participants receive local infiltration of betamethasone and ropivacaine before spinal surgery and standard general anesthesia. Postoperative pain management includes use of a patient-controlled analgesia (PCA) pump and supplemental oral analgesics as needed.
1 preoperative visit, 1 surgery day visit, and multiple visits during 48-hour postoperative PCA monitoring
Duration - Up to 3 months postoperatively
Participants are monitored for pain, analgesic use, side effects, and recovery outcomes including quality of life and scar assessment up to 3 months after surgery.
Visits at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 6 weeks, and 3 months postoperatively
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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Yitong Wang, Bo Han, Chunmei Zhao...
https://pubmed.ncbi.nlm.nih.gov/41022457