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

• Status: Recruiting
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Suboxone treated patients present a unique challenge to providers during the perioperative period in terms of pain control. If the patient is taken off their prescribed suboxone 48 hours prior to the procedure, the opioid pain medication will function but the patient is exposed to the very medications originally responsible for their substance addiction. The discontinuation of suboxone can potentially lead to opioid addiction relapse in this situation (Anderson et al., 2017). If the patient remains on their suboxone, opioid pain medications can be ineffective or require very large dosages to control pain but the patient's risk of relapse may be lower (Anderson et al., 2017). Classic opioid pain medications prescribed by providers for post-operative pain control such as hydromorphone, morphine and fentanyl have lower affinity for the Mu 1 and 2 receptors when compared to buprenorphine. These medications are less effective or ineffective when given to a patient treated with Suboxone due to their inability to bind to the Mu receptor in the presence of buprenorphine. The only clinically used full agonist opioid with stronger affinity for the MU 1 and 2 receptors is sufentanil. In theory, sufentanil would be able to displace buprenorphine from the receptor and stimulate the receptor as a full agonist leading to predictable pain control. Through the Kappa receptor antagonism, buprenorphine may improve the treatment of opioid-induced hyperalgesia (Koppert W et al., 2005). Additional benefits may include buprenorphine's Kappa receptor antagonism may help in treating forms of depression and depression (Lalanne et al., 2014). At our institution, orthopedic trauma patients have a high incidence of suboxone use and make an ideal study population as they are often otherwise healthy. Our study compares opioid consumption in the perioperative period in patients taking suboxone on presentation to the operating room. The patients will randomized to receive conventional opioid based regimen versus buprenorphine and sufentanil based opioid regimen. The goal of the study is to determine if the combination of buprenorphine and sufentanil based pain control is superior to classic opioid treatment strategies in patients taking suboxone while presenting for orthopedic trauma surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University
• Collaborator: West Virginia Clinical and Translational Science Institute
• Treatments: Buprenorphine; Sufentanil

Criteria

Inclusion Criteria:

• 1.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) 2.Must have taken suboxone in the last 24 hours and have participated in addiction treatment for greater than one month.

3.Age 18-65 4.ASA I-III 5.Willing to participate in post-operative psychiatric care 6.Glascow Coma Scale 15

Exclusion Criteria:

• Severe renal disease (Creatinine clearance < 40) 2.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? 3.Acute Ethanol Intoxication (serum ethanol > 0.080 at time of informed consent) 4.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) 5.Pregnancy 6.Polysubstance abuse on urine or serum drug screen (excluding marijuana due to its new legality in multiple states)