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

• ClinicalTrials.gov Identifier: NCT06113211
• Recruitment Status: Not yet recruiting
• First Posted: November 2, 2023
• Last Update Posted: January 11, 2024
• Sponsor: Henry Ford Health System
• Information provided by (Responsible Party): Henry Ford Health System

Tracking Information

• First Submitted Date: October 27, 2023
• First Posted Date: November 2, 2023
• Last Update Posted Date: January 11, 2024
• Estimated Study Start Date: June 15, 2024
• Estimated Primary Completion Date: September 15, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2023)

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. ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2023)

Patient reported function score [ Time Frame: Preoperative visit and postoperative visits up to 1 year. ]

Patient reported function questionnaire will be administered to patients during postoperative visits.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
• Official Title: Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures

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-narocotic 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:

Mortin - 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Opioid Use
• Fractures, Bone
• Trauma

Intervention

• 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.

Study Arms

• Active Comparator: Narcotic Postoperative Pain Control
  Standard of care control group given standard opioid pain control regimen.
  Intervention: Drug: Narcotic pain medication
• Experimental: Nonnarcotic Postoperative Pain Control
  Experimental group given nonopioid pain control regimen.
  Intervention: Drug: Nonnarcotic pain medications

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 27, 2023): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 15, 2025
• Estimated Primary Completion Date: September 15, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: William Hakeos; 3132055349; whakeos1@hfhs.org

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06113211
• Other Study ID Numbers: 15315
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Henry Ford Health System
• Original Responsible Party: Same as current
• Current Study Sponsor: Henry Ford Health System
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Henry Ford Health System
• Verification Date: January 2024