Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.

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

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Acetaminophen; BB 1101; Celecoxib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gabapentin; Narcotics; Oxycodone

Criteria

Inclusion Criteria:

• Bone fracture

• Isolated injury

• Requires operative intervention

Exclusion Criteria:

• pathological fractures

• inability to personally consent to participation due to cognitive impairment, intoxication or sedation

• severe head injury

• polytrauma patients with multiple fractures or other injuries

• pregnancy

• open fractures

• metabolic bone disease

• allergies or contraindications to the study medications, including sulfa medications.

• prior or current drug or alcohol dependence or abuse

• liver or kidney disease

• physician directed narcotic use