drugset / Trial / NCT04464512

Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population

NCT04464512

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized controlled trial. Patients will be randomly assigned to either the control or treatment group, with equal allocation using block randomization. The primary null hypothesis is that a combination sufentanil and buprenorphine based pain control regimen will not result in lower morphine equivalent requirements for pain control when compared to a classic fentanyl and hydromorphone based regimen. The secondary working hypothesis is that the patient satisfaction survey mean satisfaction scores will be higher in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The secondary null hypothesis is that the patient satisfaction surveys mean scores will not be significantly different in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The tertiary working hypothesis is that the patients will have significantly lower rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks. The tertiary null hypothesis is that patients have equivalent rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks.

Timeline

Start
2020-01-10
Primary completion
2021-08-22
Completion
2021-08-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buprenorphine Other / unclassified 2 mg Intravenous
Comparator Sufentanil Other / unclassified 0.01 ug/kg Intravenous
Comparator Sufentanil Other / unclassified 0.03 ug/kg Intravenous