drugset / Trial / NCT03693404
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
Timeline
- Start
- 2018-12-01
- Primary completion
- 2021-06-05
- Completion
- 2021-06-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 0.25 % | Other |
| Subject | Bupivacaine | Other / unclassified | 10 ml | Other |
| Subject | Bupivacaine | Other / unclassified | 40 ml | Other |
| Subject | Ketorolac | Other / unclassified | 30 mg | Other |
| Subject | Morphine | Other / unclassified | 5 mg | Other |
Indications
No indication recorded.