Status:
WITHDRAWN
Suboxone User Perioperative Early Referral and Enhanced Recovery After Surgery- Orthopaedic Trauma Surgery Population
Lead Sponsor:
West Virginia University
Collaborating Sponsors:
West Virginia Clinical and Translational Science Institute
Conditions:
Addiction Opiate
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
After determining the patient qualifies for the study, the patient would then be taken through the informed consent process by one of the co-investigators in the orthopedics group at West Virginia Uni...
Eligibility Criteria
Inclusion
- Orthopaedic trauma patient with history of suboxone use for greater than 30 days. Trauma must involve major long bone fracture(s) (femur, tibia, fibula, humerus, radius, ulna) .Must have taken suboxone in the last 24 hours and have participated in addiction treatment for greater than one month.
- Age 18-65
- ASA I-III
- Willing to participate in post-operative psychiatric care
- Glascow Coma Scale 15
Exclusion
- Severe renal disease (Creatinine clearance \< 40)
- History of chronicSevere liver disease or an (AST/ALT greater than 2 times normal, direct/indirect bilirubin outside normal limits and INR\> 1.4 if drawn as standard of care) or evidence of acute liver failure
- Acute Ethanol Intoxication (serum ethanol \> 0.080 at time of informed consent)
- Severe distracting injury that is close to pain levels expected from the orthopedic trauma (Ex surgical abdominal process, neurosurgical process, massive soft tissue trauma, severe spinal injury, multiple rib fractures)
- Pregnancy
- Polysubstance abuse on urine or serum drug screen (excluding marijuana due to its new legality in multiple states)
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04464512
Start Date
January 10 2020
End Date
August 22 2021
Last Update
December 12 2022
Active Locations (1)
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1
West Viriginia University Hospital
Morgantown, West Virginia, United States, 26506