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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| General Anesthesia | Active Comparator | The control group will receive no injection into area surrounding the fracture site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine, Duramorph , ketorolac | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used | Number of mgs taken of oral morphine | 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. | 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. | Hour 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Leucht, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37199438 | Derived | 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. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | General Anesthesia | The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia |
| FG001 | Spinal Anesthesia | 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. Marcaine, Duramorph , ketorolac: 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): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | General Anesthesia | The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia |
| BG001 | Spinal Anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used | Number of mgs taken of oral morphine | Posted | Mean | Standard Deviation | morphine milligram equivalents (MME) | Post-Operative Day 0 |
|
3 months
regular investigator assessment / questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Anesthesia | The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philipp Leucht, MD | NYU Langone Health | 646-501-0291 | philipp.leucht@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2020 | Jun 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009020 | Morphine |
| D020910 | Ketorolac |
| D018681 | Anesthetics, General |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Bupivacaine (Marcaine) | Drug | 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. |
|
| General Anesthetics | Drug | Placebo group will only receive standard of care general anesthesia |
|
| Excluded from Analysis |
|
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.
Marcaine, Duramorph , ketorolac: 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): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Feet | Post-operative Day 3 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Hour 24 |
|
|
|
| 0 |
| 109 |
| 0 |
| 109 |
| 0 |
| 109 |
| EG001 | Spinal Anesthesia | 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. Marcaine, Duramorph , ketorolac: 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): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. | 0 | 81 | 0 | 81 | 0 | 81 |
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| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |