Pertrochanteric FracturePhase 4NCT03693404
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
A Phase 4 study testing Marcaine, Duramorph , ketorolac, Bupivacaine (Marcaine) and General Anesthetics in people with Pertrochanteric Fracture, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric Fracture
- What is being tested?
- Marcaine, Duramorph , ketorolac, Bupivacaine (Marcaine) and General Anesthetics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 5 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture
Who cannot join
- Pregnant women
- Treatment with Arthroplasty
- Patients who receive a peripheral nerve block
- Patients who receive intra-op or post-op ketamine
- Patients with concomitant TBI or MR
- Polytrauma patients
Show all 13Show fewer
- Pathologic Fractures
- Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider
- Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance
- Patients with prior extremity weakness resulting from stroke or other neurological condition
- Prior or current history of narcotic use
- Patients with advanced dementia
- NYUMC Students, Residents, Faculty
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Health
New York, New York, 10016
About this study
This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
- Conditions
- Pertrochanteric Fracture
- Being tested
- Marcaine, Duramorph , ketorolac, Bupivacaine (Marcaine), General Anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine, Duramorph , ketorolacDrug
Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Bupivacaine (Marcaine)Drug
0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
General AnestheticsDrug
Placebo group will only receive standard of care general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia | Experimental | Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Receives: Drug: Marcaine, Duramorph , ketorolac; Drug: Bupivacaine (Marcaine) |
| General Anesthesia | Active comparator | The control group will receive no injection into area surrounding the fracture site Receives: Drug: General Anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used
Number of mgs taken of oral morphine
Measured: Post-Operative Day 0
Ambulation Distance
Ambulation is the ability to walk without the need for any kind of assistance. It is most often used when describing the goals of a patient after a surgery or physical therapy.
Measured: Post-operative Day 3
Score on Visual Analogue Scale (VAS) for Pain
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Dec 2018
- Primary completion5 Jun 2021
- Study completion5 Jun 2021
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 Pertrochanteric FractureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Leucht, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693404
- Sponsor's protocol ID
- 18-01019
- Status last verified
- Jun 2022
- First submitted
- 1 Oct 2018
- Last updated
- 21 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Ihejirika-Lomedico R, Solasz S, Lorentz N, Egol KA, Leucht P; and NYU Hip Fracture Research Group. Effects of Intraoperative Local Pain Cocktail Injections on Early Function and Patient-Reported Outcomes: A Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):433-439. doi: 10.1097/BOT.0000000000002628.
PubMed 37199438
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
- ClinicalTrials.gov ID
- NCT03693404
- Acronym / sponsor ID
- 18-01019
- Conditions
- Pertrochanteric Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 21 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Experimental | Drug: Marcaine, Duramorph , ketorolac, Drug: Bupivacaine (Marcaine)Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. |
| General Anesthesia | Active comparator | Drug: General AnestheticsThe control group will receive no injection into area surrounding the fracture site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture
Key exclusion criteria (13 listed)
- Pregnant women
- Treatment with Arthroplasty
- Patients who receive a peripheral nerve block
- Patients who receive intra-op or post-op ketamine
- Patients with concomitant TBI or MR
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 |
|---|---|---|
| Marcaine, Duramorph , ketorolacSubjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. | Drug | Spinal Anesthesia |
| Bupivacaine (Marcaine)0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. | Drug | Spinal Anesthesia |
| General AnestheticsPlacebo group will only receive standard of care general anesthesia | Drug | General Anesthesia |
Primary outcome
Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used
Time frame: Post-Operative Day 0
Number of mgs taken of oral morphine
Ambulation Distance
Time frame: Post-operative Day 3
Ambulation is the ability to walk without the need for any kind of assistance. It is most often used when describing the goals of a patient after a surgery or physical therapy.
Score on Visual Analogue Scale (VAS) for Pain
Time frame: Hour 24
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37199438Ihejirika-Lomedico R, Solasz S, Lorentz N, Egol KA, Leucht P; and NYU Hip Fracture Research Group. Effects of Intraoperative Local Pain Cocktail Injections on Early Function and Patient-Reported Outcomes: A Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):433-439. doi: 10.1097/BOT.0000000000002628.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Pertrochanteric Fracture
Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Hip Fracture of Intertrochanteric Type
Recruiting
One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures
Hip Fractures
Recruiting
Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A
Pertrochanteric Fracture
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.
Philipp Leucht, MD principal investigator
NYU Langone Health
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 Marcaine, Duramorph , ketorolac, Bupivacaine (Marcaine) and General Anesthetics in people with Pertrochanteric Fracture, run by NYU Langone Health 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 1 inclusion and 13 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 21 Jul 2022. 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. 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 21 Jul 2022). 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?
Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used (time frame: Post-Operative Day 0). The study lists 3 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 NCT03693404, 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 21 Jul 2022.