NCT06801587

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

Preemptive Co-infiltration of Triamcinolone Acetonide With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Fang Luo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing major spinal surgery usually experience moderate to-severe postoperative pain. Inadequate pain control may lead to severe complications. Local infiltration analgesia (LIA) with a local anesthetic, is a simple, minimally invasive, and effective postoperative pain management technique. However, LIA with local anesthetic alone can only last for a short time, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. Triamcinolone acetonide as an adjunctive infiltration to local anesthesia presented a superior analgesic benefit compared with local anesthesia alone in various types of surgeries. To date, no studies have evaluated the additive analgesia effects of triamcinolone acetonide on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of triamcinolone acetonide and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.

Conditions

• Pain
• Postoperative

Interventions

Type	Name	Description
DRUG	Triamcinolone acetonide plus ropivacaine	The local infiltration solution in the triamcinolone acetonide plus ropivacaine group will consist of ropivacaine and triamcinolone acetonide. For local infiltration, a total of 30mL solution will be prepared for each group, 1 ml of triamcinolone acetonide (40mg per 1ml) plus 15 ml of 1% ropivacaine diluted to 30 ml with saline as the test drug in the triamcinolone acetonide group. The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.
DRUG	Ropivacaine alone	The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 15ml of ropivacaine added to 15mL of saline for ropivacaine group . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.

Timeline

• Start date: 2025-02-05
• Primary completion: 2025-05-10
• Completion: 2025-08-10
• First posted: 2025-01-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China