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Withdrawn Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT04464512

Public ClinicalTrials.gov record NCT04464512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04464512
Recruitment status
Withdrawn
Study type
Interventional
Phase
Phase 4
Lead sponsor
West Virginia University
Other
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 9, 2020
Primary completion
Aug 21, 2021
Completion
Aug 21, 2021
Last update posted
Dec 11, 2022

2020 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
West Viriginia University Hospital Morgantown West Virginia 26506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04464512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 11, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04464512 live on ClinicalTrials.gov.

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