MedTrace Logo

Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures

NCT06113211 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-13

No results posted yet for this study

Summary

An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain.

Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen.

Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding.

On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence.

If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed.

Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.

Conditions

  • Opioid Use
  • Fractures, Bone
  • Trauma

Interventions

DRUG

Narcotic pain medication

Primary intervention is pain medication received postoperatively. Control group will receive the standard of care which is opioid medications. Experimental group will receive a nonopioid pain control regimen.

DRUG

Nonnarcotic pain medications

Primary intervention is pain medication received postoperatively. Control group will receive the standard of care which is opioid medications. Experimental group will receive a nonopioid pain control regimen.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-09-15
Completion
2026-09-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06113211 on ClinicalTrials.gov