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

NCT06113211 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 15315
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Analog pain score 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.

  Pain scores will be recorded daily for the first 2 weeks, and then once a week until the 6 week post operative clinic visit.

Secondary Outcomes (1)

• Patient reported function score

  Preoperative visit and postoperative visits up to 1 year.

Study Arms (2)

Narcotic Postoperative Pain Control

ACTIVE COMPARATOR

Standard of care control group given standard opioid pain control regimen.

Drug: Narcotic pain medication

Nonnarcotic Postoperative Pain Control

EXPERIMENTAL

Experimental group given nonopioid pain control regimen.

Drug: Nonnarcotic pain medications

Interventions

Narcotic pain medication DRUG

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.

Narcotic Postoperative Pain Control

Nonnarcotic pain medications DRUG

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.

Nonnarcotic Postoperative Pain Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients with a medical history of known allergies or intolerance to allergies or intolerance to Motrin, Lyrica, Tylenol, tramadol, Zanaflex
• substantial alcohol or drug abuse
• pregnancy
• history of narcotics within 6 months of surgery
• renal impairment, peptic ulcer disease, GI bleeding.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital System

Detroit, Michigan, 48226, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries

Central Study Contacts

William Hakeos

CONTACT

3132055349; whakeos1@hfhs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)