Recruiting

Nonopioid Pain Control

Sponsor:

Henry Ford Health System

Code:

NCT06113211

Conditions

Opioid Use

Fractures, Bone

Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Narcotic pain medication

Nonnarcotic pain medications

Study Details

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

Study ID

NCT06113211

Start date

Oct 1, 2024

Status verified date

Feb, 2026

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult patients over age eighteen and scheduled for primary open reduction internal fixation following a traumatic fracture at Henry Ford Hospital (Detroit, Michigan, United States), and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States) will be eligible for inclusion in this study. All patients will be met in our abulatory orthopedic clinics. All surgeries will be performed by a fellowship trained truama surgeons.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Narcotic Postoperative Pain Control

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

experimental: Nonnarcotic Postoperative Pain Control

Experimental group given nonopioid pain control regimen.

Interventions

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.

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.

Primary outcome measure

  • Pain Score [ Time Frame: Pain scores will be recorded daily for the first 2 weeks, and then once a week until the 6 week post operative clinic visit. ]

Central Contacts and Locations

Central contacts

Locations

Henry Ford Hospital System

Recruiting

Detroit, Michigan, United States, 48226

Contacts

William Hakeos, MD

whakeos1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Apr 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-04-13.