Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
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| ClinicalTrials.gov Identifier: NCT06113211 |
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Recruitment Status :
Not yet recruiting
First Posted : November 2, 2023
Last Update Posted : January 11, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opioid Use Fractures, Bone Trauma | Drug: Narcotic pain medication Drug: Nonnarcotic pain medications | Phase 4 |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures |
| Estimated Study Start Date : | June 15, 2024 |
| Estimated Primary Completion Date : | September 15, 2025 |
| Estimated Study Completion Date : | September 15, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Narcotic Postoperative Pain Control
Standard of care control group given standard opioid pain control regimen.
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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. |
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Experimental: Nonnarcotic Postoperative Pain Control
Experimental group given nonopioid pain control regimen.
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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. |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06113211
| Contact: William Hakeos | 3132055349 | whakeos1@hfhs.org |
Documents provided by Henry Ford Health System:
| Responsible Party: | Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT06113211 |
| Other Study ID Numbers: |
15315 |
| First Posted: | November 2, 2023 Key Record Dates |
| Last Update Posted: | January 11, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Fractures, Bone Wounds and Injuries Narcotics Analgesics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |