Be an issue. So we compromised on two weeks. Pain scores and quality-of-life were improved in the operative arm. Unfortunately narcotics did not reach significance(the dreaded p=0.05), But we still saw a strong signal out to eight week follow up. #eastjc
We are actually doing a single center RCT in Denver of Pain catheter versus one time liposomal bupivacaine injection in the OR during SSRF. 31/45 subjects enrolled. I think there will be some power issues. This kind of question would be great for a multi center study.#eastjc
I would be very interested in others’ thoughts on what the next RCT in the non-flail population should look like. In NON-FLAIL, we use three or more displaced fractures with respiratory compromise but not intubated. Surgery within 72 hours. #eastjc
Yes interesting is one word for it! we expected a high rate of refusing randomization- and in fact it was 80%. People (understandably) just weren’t willing to accept a random decision to get an operation. - #eastjc
Including an observational arm allowed us to accrue subjects relatively quickly, thereby minimizing other changes in practice over the study timeline, and maintaining enthusiasm. #eastjc
This of course comes at the expense of potential bias, we we did not find any differences between those who selected surgery and those who didn’t. We showed every subject a standard video explaining that there was no proven benefit to surgery, and had house staff #eastjc
In any one direction. If we waited to get to 110 subjects w randomization- study would have taken 10 years- even w 12 centers. I plan on being retired on a beach by then... #eastjc