drugset / Trial / NCT04860856

Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

NCT04860856 ↗

Phase 4 Completed 88 enrolled University of Cincinnati
RandomizedSingle-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.

Timeline

Start
2019-08-17
Primary completion
2023-02-07
Completion
2023-02-07

Outcome

Met primary endpoint

paper The treatment group demonstrated significantly lower VAS pain scores than the control group in the first 24-hour postoperative period (5.0 vs. 6.7, P = 0.004) PMID 37199424 ↗

paper In addition, the opioid consumption (morphine milligram equivalents) was significantly lower in the treatment group compared with the control group over the first 24-hour postoperative period (43.6 vs. 65.9, P = 0.008). PMID 37199424 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 100 mg Other

Indications