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

NCT04464512 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 1802003669
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Addiction Opiate; Chronic Pain; Fractures, Bone; Buprenorphine Dependence

Outcome Measures

Primary Outcomes (1)

• Pain Medication Used

  Total amount of pain medication used

  up to 4 weeks

Secondary Outcomes (1)

• Patient Satisfaction Survey Results

  Post operative day number 2

Study Arms (2)

Standard (control) treatment

NO INTERVENTION

The control group receives 1mcg/kg fentanyl followed by fentanyl 0.5-1mcg/kg q10 minute PRN, ketorolac 0.5mg/kg up to 30mg max IV, and acetaminophen 1000mg IV for pain control intraoperatively. The patient is then treated with hydromorphone 0.005mg/kg q10minutes the post-anesthesia recovery. The patient would then receive hydromorphone 0.005 mg/kg q1hr PRN, 1 gram acetaminophen IV scheduled q6hr, and methocarbamol 750mg QID following discharge from the PACU and transfer to the hospital floor. The patient is converted to oxycodone 10mg (Roxicodone) q4hr PRN and 975 mg PO APAP scheduled for pain control on postoperative day number 1 or when appropriate for PO intake. The patients receives their home dose of suboxone onpostoperative day number 1 or when appropriate for PO intake. On postoperative day number 2 number 3, patients are transitioned to an increased dose of their Suboxone for pain control in preparation for discharge.

Treatment Group

ACTIVE COMPARATOR

Buprenorphine-sufentanil group receives sufentanil 0.03mcg/kg followed by sufentanil 0.01-0.03 mcg/kg q10 min PRN, IV ketorolac 0.5mg/kg up to 30mg max and IV acetaminophen 15mg/kg up to 1000mg for pain control intraoperatively. In the PACU, IV buprenorphine 0.3mg IV q30 minutes would be given as the first line choice for pain control for 3 doses. IV PCA sufentanil is used as a second line therapy if patient comfort is not achieved by IV buprenorphine alone. The patient receives 0.3 mg buprenorphine IV Q6hr PRN, scheduled IV acetaminophen 1 gram for 24 hrs and methocarbamol 750mg QID after discharge from the PACU and transfer to the floor. The patient is converted to buprenorphine2mg q6hr PRN and 975 gram PO APAP scheduled for pain control on postoperative day 1. The patient receives their home dose of Suboxone starting on postoperative day 1 if tolerating PO intake. On postoperative day 2, patients would be transitioned to an increased dose of their Suboxone.

Drug: Sufentanil

Interventions

Sufentanil DRUG

IV buprenorphine plus IV sufentanil treatment group.

Also known as: Buprenorphine

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• West Virginia University: lead
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

West Viriginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain; Fractures, Bone

Interventions

Sufentanil; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blind to the treatment/group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professory of Anesthesiology

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 9, 2020
• Study Start: January 10, 2020
• Primary Completion: August 22, 2021
• Study Completion: August 22, 2021
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

US (1)