Femur FracturePhase 4NCT04761302
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
A Phase 4 study testing Intravenous ketorolac and oral acetaminophen and Intravenous morphine and oral oxycodone in people with Femur Fracture and Tibial Fractures, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Femur Fracture, Tibial Fractures
- What is being tested?
- Intravenous ketorolac and oral acetaminophen and Intravenous morphine and oral oxycodone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 18 Apr 2021to 1 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with tibial and femoral shaft fractures
- Patients undergoing intramedullary nailing
- Willing to participate in the protocol
Who cannot join
- Chronic pain disorder (daily use of oral opioids)
- Allergy or hypersensitivity to non steroid anti-inflammatory drug
- Impaired renal, cardiac, or hepatic function
- History of gastrointestinal bleeding or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.
Read the detailed description
The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).
- Conditions
- Femur Fracture, Tibial Fractures
- Being tested
- Intravenous ketorolac and oral acetaminophen, Intravenous morphine and oral oxycodone
- Keywords
- Opioid use, Post-operative pain, Analgesic use, Femur fracture, Tibia fracture, Intramedullary Nailing
- Medical subject headings
- Femoral Fractures, Tibial Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ketorolac and oral acetaminophenDrug
ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group
Intravenous morphine and oral oxycodoneDrug
Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen | Experimental | Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. Receives: Drug: Intravenous ketorolac and oral acetaminophen |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone | Active comparator | Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. Receives: Drug: Intravenous morphine and oral oxycodone |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Experimental | Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. Receives: Drug: Intravenous ketorolac and oral acetaminophen |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone | Active comparator | Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. Receives: Drug: Intravenous morphine and oral oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
12hrs VAS Pain Scores
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Measured: Measured at postoperative hour 12
24hrs VAS Pain Score
Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)
Measured: Measured at postoperative hour 24
36hrs VAS Pain Scores
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Measured: Measured at postoperative hour 36
48hrs VAS Pain Scores
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Measured: Measured at postoperative hour 48
12hrs MME
Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)
Measured: Measured at postoperative hour 12
24hrs MME
Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)
Measured: Measured at postoperative hour 24
36hrs MME
Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)
Measured: Measured at postoperative hour 36
48hrs MME
Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)
Measured: Measured at postoperative hour 48
Secondary outcomes (1)
Hospital Length of Stay
Time from intervention to discharge
Measured: Determined by discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start18 Apr 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis F. Lojo-Sojo, MD, Principal investigator, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761302
- Sponsor's protocol ID
- A9290220
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2021
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.
PubMed 38579315
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
- ClinicalTrials.gov ID
- NCT04761302
- Acronym / sponsor ID
- A9290220
- Conditions
- Femur Fracture, Tibial Fractures
- Keywords
- Opioid use, Post-operative pain, Analgesic use, Femur fracture, Tibia fracture, Intramedullary Nailing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.
Detailed description
The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen | Experimental | Drug: Intravenous ketorolac and oral acetaminophenGroup 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone | Active comparator | Drug: Intravenous morphine and oral oxycodoneGroup 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Experimental | Drug: Intravenous ketorolac and oral acetaminophenGroup 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone | Active comparator | Drug: Intravenous morphine and oral oxycodoneGroup 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with tibial and femoral shaft fractures
- Patients undergoing intramedullary nailing
- Willing to participate in the protocol
Key exclusion criteria (4 listed)
- Chronic pain disorder (daily use of oral opioids)
- Allergy or hypersensitivity to non steroid anti-inflammatory drug
- Impaired renal, cardiac, or hepatic function
- History of gastrointestinal bleeding or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ketorolac and oral acetaminophenketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group | Drug | Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen, Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen |
| Intravenous morphine and oral oxycodoneMorphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. | Drug | Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone, Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone |
Primary outcome
12hrs VAS Pain Scores
Time frame: Measured at postoperative hour 12
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
24hrs VAS Pain Score
Time frame: Measured at postoperative hour 24
Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)
36hrs VAS Pain Scores
Time frame: Measured at postoperative hour 36
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
48hrs VAS Pain Scores
Time frame: Measured at postoperative hour 48
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
12hrs MME
Time frame: Measured at postoperative hour 12
Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)
24hrs MME
Time frame: Measured at postoperative hour 24
Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)
36hrs MME
Time frame: Measured at postoperative hour 36
Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)
48hrs MME
Time frame: Measured at postoperative hour 48
Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)
1 secondary outcome
Hospital Length of Stay
Time frame: Determined by discharge date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38579315Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F. Lojo-Sojo, MD principal investigator
Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous ketorolac and oral acetaminophen and Intravenous morphine and oral oxycodone in people with Femur Fracture and Tibial Fractures, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12hrs VAS Pain Scores (time frame: Measured at postoperative hour 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.