drugset / Trial / NCT06785350

Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery

NCT06785350

Recruiting 535 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.

Timeline

Start
2025-01-25
Primary completion
2025-09-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject betamethasone dipropionate Small molecule 0.003 % Other
Subject betamethasone dipropionate Small molecule 0.006 % Other
Subject betamethasone dipropionate Small molecule 0.009 % Other
Subject betamethasone dipropionate Small molecule 0.012 % Other
Comparator Ropivacaine Other / unclassified 0.5 % Other

Indications

No indication recorded.