Femur FracturePhase 4NCT04860856
Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial
A Phase 4 study testing 0.5% ropivacaine and Normal Saline in people with Femur Fracture, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- 0.5% ropivacaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2019to 7 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma patient at the University of Cincinnati Medical Center
- Skeletally mature patients
- Have an isolated, closed, acute traumatic femoral shaft fracture to be treated with a closed reduction and reamed intramedullary rod fixation
Who cannot join
- Unable to provide informed consent
- Member of a vulnerable patient population
- Have additional injuries
- Have a history of prior existing narcotic use or chronic pain management issues on presentation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
About this study
The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.
Read the detailed description
This blinded, randomized control trial is being performed at the University of Cincinnati Medical Center.
Patients will be randomly assigned to one of two treatment groups: Group One will be comprised of patients treated with fracture site injection containing 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length), Group Two will be comprised of patients treated with fracture site injection containing 20ml of normal saline. The injection will be administered by the orthopaedic trauma team after the insertion of the final intramedullary implant and skin closure prior to final surgical dressing application. The injection will be performed in a standard fashion with aspiration of hematoma followed by the injection. All postoperative management will be per standard of care.
The size of the hematoma will have no effect on the procedure. When a hematoma block is utilized in the care of orthopaedic trauma patients, its aim is to infiltrate the anesthetic to the fracture edges and injured soft tissue to allow for pain control and fracture manipulation without additional sedation. Aspiration of the hematoma tells the clinician that the tip of the needle is near the fracture site and not in a neurovascular structure.
The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.
Regional anesthesia including nerve blocks is not routinely used in the setting of traumatic femoral shaft fractures. A nerve block would compromise the patient's neurologic examination in the immediate postoperative period.
Randomization will be performed via Microsoft Excel to generate random numbers. Allocation will be concealed and revealed to the surgical team in the hour prior to the procedure. The patients and the nursing staff who assess postoperative pain will be blinded to the treatment allocation.
An a priori power analysis was performed to determine the sample size for the primary outcome measure. Prior literature has indicated that a difference of 1.3 on a VAS is clinically significant.5 Therefore, it was determined that a total of 44 patients were necessary per group to detect a 1.5-point difference on the VAS (power = 80%, p = 0.05).
- Conditions
- Femur Fracture
- Being tested
- 0.5% ropivacaine, Normal Saline
- Keywords
- Femoral Intramedullary Rod, Hematoma Block
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% ropivacaineDrug
The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.
Normal SalineDrug
20ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Hematoma block | Experimental | Fracture site injection of 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length). Receives: Drug: 0.5% ropivacaine |
| Normal saline injection | Placebo comparator | Fracture site injection of 20ml of normal saline. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain at 72 hours
Postoperative pain will be assessed using a visual analog scale
Measured: Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively
Secondary outcomes (1)
Narcotic usage
Oral morphine equivalents will be recorded
Measured: Narcotic usage will be assessed through 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start17 Aug 2019
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Blinded, randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruixian Yue, University of Cincinnati
- Investigators
- He C S, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860856
- Sponsor's protocol ID
- OS19011 IRB 2019-0366
- Status last verified
- Feb 2023
- First submitted
- 19 Apr 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alioto RJ, Furia JP, Marquardt JD. Hematoma block for ankle fractures: a safe and efficacious technique for manipulations. J Orthop Trauma. 1995 Apr;9(2):113-6. doi: 10.1097/00005131-199504000-00004.
PubMed 7776029Bear DM, Friel NA, Lupo CL, Pitetti R, Ward WT. Hematoma block versus sedation for the reduction of distal radius fractures in children. J Hand Surg Am. 2015 Jan;40(1):57-61. doi: 10.1016/j.jhsa.2014.08.039. Epub 2014 Oct 11.
PubMed 25306504Case RD. Haematoma block--a safe method of reducing Colles' fractures. Injury. 1985 Jul;16(7):469-70. doi: 10.1016/0020-1383(85)90168-8.
PubMed 4030071Herrera JA, Wall EJ, Foad SL. Hematoma block reduces narcotic pain medication after femoral elastic nailing in children. J Pediatr Orthop. 2004 May-Jun;24(3):254-6. doi: 10.1097/00004694-200405000-00003.
PubMed 15105718Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
PubMed 11719741Koehler D, Marsh JL, Karam M, Fruehling C, Willey M. Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 15;99(6):512-519. doi: 10.2106/JBJS.16.00733.
PubMed 28291185Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.
PubMed 1749663Dimopoulou I, Anagnostou TL, Prassinos NN, Savvas I, Patsikas M. Effect of intrafragmentary bupivacaine (haematoma block) on analgesic requirements in dogs undergoing fracture repair. Vet Anaesth Analg. 2017 Sep;44(5):1189-1197. doi: 10.1016/j.vaa.2017.01.005. Epub 2017 Mar 6.
PubMed 29100681Yue RA, Shah NS, Matar RN, Sagi HC. Efficacy of Hematoma Block After Intramedullary Rod Fixation of Femoral Shaft Fractures: A Prospective, Double-Blinded, Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):429-432. doi: 10.1097/BOT.0000000000002623.
PubMed 37199424
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04860856
- Acronym / sponsor ID
- OS19011 IRB 2019-0366
- Conditions
- Femur Fracture
- Keywords
- Femoral Intramedullary Rod, Hematoma Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 17 Aug 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
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 study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.
Detailed description
This blinded, randomized control trial is being performed at the University of Cincinnati Medical Center.
Patients will be randomly assigned to one of two treatment groups: Group One will be comprised of patients treated with fracture site injection containing 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length), Group Two will be comprised of patients treated with fracture site injection containing 20ml of normal saline. The injection will be administered by the orthopaedic trauma team after the insertion of the final intramedullary implant and skin closure prior to final surgical dressing application. The injection will be performed in a standard fashion with aspiration of hematoma followed by the injection. All postoperative management will be per standard of care.
The size of the hematoma will have no effect on the procedure. When a hematoma block is utilized in the care of orthopaedic trauma patients, its aim is to infiltrate the anesthetic to the fracture edges and injured soft tissue to allow for pain control and fracture manipulation without additional sedation. Aspiration of the hematoma tells the clinician that the tip of the needle is near the fracture site and not in a neurovascular structure.
The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.
Regional anesthesia including nerve blocks is not routinely used in the setting of traumatic femoral shaft fractures. A nerve block would compromise the patient's neurologic examination in the immediate postoperative period.
Randomization will be performed via Microsoft Excel to generate random numbers. Allocation will be concealed and revealed to the surgical team in the hour prior to the procedure. The patients and the nursing staff who assess postoperative pain will be blinded to the treatment allocation.
An a priori power analysis was performed to determine the sample size for the primary outcome measure. Prior literature has indicated that a difference of 1.3 on a VAS is clinically significant.5 Therefore, it was determined that a total of 44 patients were necessary per group to detect a 1.5-point difference on the VAS (power = 80%, p = 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Blinded, randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Hematoma block | Experimental | Drug: 0.5% ropivacaineFracture site injection of 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length). |
| Normal saline injection | Placebo comparator | Drug: Normal SalineFracture site injection of 20ml of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Trauma patient at the University of Cincinnati Medical Center
- Skeletally mature patients
- Have an isolated, closed, acute traumatic femoral shaft fracture to be treated with a closed reduction and reamed intramedullary rod fixation
Key exclusion criteria (4 listed)
- Unable to provide informed consent
- Member of a vulnerable patient population
- Have additional injuries
- Have a history of prior existing narcotic use or chronic pain management issues on presentation
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 |
|---|---|---|
| 0.5% ropivacaineThe maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg. | Drug | Hematoma block |
| Normal Saline20ml of normal saline | Drug | Normal saline injection |
Primary outcome
Change in postoperative pain at 72 hours
Time frame: Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively
Postoperative pain will be assessed using a visual analog scale
1 secondary outcome
Narcotic usage
Time frame: Narcotic usage will be assessed through 72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 7776029Alioto RJ, Furia JP, Marquardt JD. Hematoma block for ankle fractures: a safe and efficacious technique for manipulations. J Orthop Trauma. 1995 Apr;9(2):113-6. doi: 10.1097/00005131-199504000-00004.
- Background: PubMed 25306504Bear DM, Friel NA, Lupo CL, Pitetti R, Ward WT. Hematoma block versus sedation for the reduction of distal radius fractures in children. J Hand Surg Am. 2015 Jan;40(1):57-61. doi: 10.1016/j.jhsa.2014.08.039. Epub 2014 Oct 11.
- Background: PubMed 4030071Case RD. Haematoma block--a safe method of reducing Colles' fractures. Injury. 1985 Jul;16(7):469-70. doi: 10.1016/0020-1383(85)90168-8.
- Background: PubMed 15105718Herrera JA, Wall EJ, Foad SL. Hematoma block reduces narcotic pain medication after femoral elastic nailing in children. J Pediatr Orthop. 2004 May-Jun;24(3):254-6. doi: 10.1097/00004694-200405000-00003.
- Background: PubMed 11719741Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
- Background: PubMed 28291185Koehler D, Marsh JL, Karam M, Fruehling C, Willey M. Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 15;99(6):512-519. doi: 10.2106/JBJS.16.00733.
- Background: PubMed 1749663Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.
- Background: PubMed 29100681Dimopoulou I, Anagnostou TL, Prassinos NN, Savvas I, Patsikas M. Effect of intrafragmentary bupivacaine (haematoma block) on analgesic requirements in dogs undergoing fracture repair. Vet Anaesth Analg. 2017 Sep;44(5):1189-1197. doi: 10.1016/j.vaa.2017.01.005. Epub 2017 Mar 6.
- Derived from this study: PubMed 37199424Yue RA, Shah NS, Matar RN, Sagi HC. Efficacy of Hematoma Block After Intramedullary Rod Fixation of Femoral Shaft Fractures: A Prospective, Double-Blinded, Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):429-432. doi: 10.1097/BOT.0000000000002623.
- 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.
He C S, MD principal investigator
University of Cincinnati
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 0.5% ropivacaine and Normal Saline in people with Femur Fracture, run by University of Cincinnati at 1 site in United States.
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 16 Feb 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in postoperative pain at 72 hours (time frame: Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively). 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 NCT04860856, which also lists 9 linked publications.
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 16 Feb 2023.