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

NCT ID: NCT06113211

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-09-15

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.

Detailed Description

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 Truama 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.

The traditional narcotic intervention is: 60 pills of Norco 5-325 q4 hours PRN.

Patients in the nonnarcotic and narocotic intervention will be given the following pre-operative pain protocol:

Celebrex 400mg PO, Lyrica 75mg x1 dose pre-op, Tramadol 50mg x 1

Patients in the non-narcotic and narcotic intervention will be given the following intraoperative pain injection:

Epinephrine 1mg (1mL), 0.5% ropivacaine (60mL), Acetaminophen 1000mg IV, Toradol 30mg (1ml)

Postoperative day 1:

Motrin - also known as ibuprofen 800 mg every 6 hours; not to exceed 3200 mg/day

Lyrica - also known as pregabalin 75mg q12hr

Tylenol - also known as acetaminophen 1000mg PO q8hr PRN pain

Zanaflex - also know as tizanidine 4mg PO q6hr

The Postoperative pain control will be as follows:

Weeks 1 and 2:

1. Motrin - also known as Ibuprofen (for 2 weeks) 800 mg every 6 hours; not to exceed 3200 mg/day

2. Lyrica (also known as pregabalin) 75mg twice per day for 5 days then wean off as described below. Dispense: 30 tablets at discharge (75mg/tablet). Days 6-7: morning-75mg; evening- 75mg. Days 8-9: morning-75mg. Days 10: No more Lyrica

3. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do not exceed a total of 4 grams of Acetaminophen per day.

4. Zanaflex (also known as tizanidine) 4 mg every 6-12 hours for 2 weeks. Weeks 2 - 4: 1. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do Not exceed a total of 4 grams of Acetaminophen per day.

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Narcotic Postoperative Pain Control

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

Group Type: ACTIVE_COMPARATOR

Narcotic pain medication

Intervention Type: 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

Experimental group given nonopioid pain control regimen.

Group Type: EXPERIMENTAL

Nonnarcotic pain medications

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henry Ford Hospital System

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William Hakeos

Role: CONTACT

whakeos1@hfhs.org

3132055349

Facility Contacts

William Hakeos, MD

Role: primary

whakeos1@hfhs.org

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

15315

Identifier Type: -

Identifier Source: org_study_id