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Search / Trial NCT06801587

Preemptive Co-infiltration of Triamcinolone Acetonide with Ropivacaine for Postoperative Pain in Major Spinal Surgery

Launched by FANG LUO · Jan 25, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to manage pain for patients undergoing major spinal surgery, such as laminoplasty or laminectomy. Typically, after such surgeries, patients experience moderate to severe pain, which can lead to complications if not managed properly. The study aims to see if combining two medications—triamcinolone acetonide (a type of steroid) and ropivacaine (a local anesthetic)—in the area of the surgery can help reduce pain more effectively than using ropivacaine alone. The researchers hope that this approach will decrease the need for opioid pain medications after surgery.

To participate in this trial, you need to be between 18 and 65 years old and scheduled for elective spinal surgery. You should be in good overall health and expected to recover quickly after surgery. However, there are certain exclusions, such as having had previous spinal surgery or certain medical conditions. If you join, you can expect to receive these medications during your surgery, and the team will monitor your pain levels afterward to see how well the treatment works. If you’re interested, make sure to discuss it with your healthcare provider to understand if this study is right for you.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18-65 years; Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia; American Society of Anesthesiologists (ASA) physical status of I-III; Anticipated full recovery and cooperation within 2 hours postoperatively.
  • Exclusion Criteria:
  • History of spinal surgery; Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS); Body mass index (BMI)\<15kg/m2 or \>35kg/m2; Peri-incisional infection; History of diabetes mellitus and other metabolic diseases; History of severe cardiopulmonary, hepatic or renal dysfunction; Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value); History of allergies to any of the study drugs; History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery; Use of systemic steroids within 1 week before surgery; History of psychiatric disorders, chronic neck or back pain; History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively; Pregnant or breastfeeding; Refusal to sign informed consent.

About Fang Luo

Fang Luo is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous methodologies. With a strong focus on collaboration, Fang Luo works closely with healthcare professionals, regulatory bodies, and research institutions to ensure the ethical conduct and scientific integrity of clinical trials. By leveraging expertise in diverse therapeutic areas, Fang Luo aims to accelerate the development of new treatments and therapies, ultimately contributing to the enhancement of global health standards.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Fang Luo

Principal Investigator

Beijing Tiantan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported