Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

PHASE4CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

June 30, 2023

Study Completion Date

September 30, 2023

Conditions
Pain, Postoperative
Interventions
DRUG

Dexamethasone palmitate emulsion(DXP) plus ropivacaine

The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . 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 7.5mL of ropivacaine added to 22.5mL of saline for Group B . 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

Beijing Tiantan Hospital

OTHER