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

PHASE4CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

February 5, 2025

Primary Completion Date

May 10, 2025

Study Completion Date

August 10, 2025

Conditions
PainPostoperative
Interventions
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.

Trial Locations (1)

100070

Beijing Tiantan Hospital, Beijing

All Listed Sponsors
lead

Fang Luo

OTHER

NCT06801587 - Preemptive Co-infiltration of Triamcinolone Acetonide With Ropivacaine for Postoperative Pain in Major Spinal Surgery | Biotech Hunter | Biotech Hunter