Pertrochanteric Fracture
Conditions
Brief 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. 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.
Interventions
DRUGMarcaine, 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.
DRUGBupivacaine (Marcaine)
0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Placebo group will only receive standard of care general anesthesia
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used | Post-Operative Day 0 | Number of mgs taken of oral morphine |
| Ambulation Distance | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 109 |
| 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. | 75 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded from Analysis | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | General Anesthesia | Total | Spinal Anesthesia |
|---|---|---|---|
| Age, Continuous | 75.5 years STANDARD_DEVIATION 15.3 | 76.5 years STANDARD_DEVIATION 13.5 | 77.5 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 18 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 95 Participants | 157 Participants | 62 Participants |
| Region of Enrollment United States | 109 participants | 184 participants | 75 participants |
| Sex: Female, Male Female | 76 Participants | 123 Participants | 47 Participants |
| Sex: Female, Male Male | 33 Participants | 61 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 81 |
| other Total, other adverse events | 0 / 109 | 0 / 81 |
| serious Total, serious adverse events | 0 / 109 | 0 / 81 |
Outcome results
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.
Time frame: Post-operative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia | Ambulation Distance | 48.7 Feet | Standard Deviation 8 |
| Spinal Anesthesia | Ambulation Distance | 88.9 Feet | Standard Deviation 17.6 |
Primary
Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used
Number of mgs taken of oral morphine
Time frame: Post-Operative Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia | Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used | 16 morphine milligram equivalents (MME) | Standard Deviation 1.5 |
| Spinal Anesthesia | Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used | 10 morphine milligram equivalents (MME) | Standard Deviation 1.4 |
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.
Time frame: Hour 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia | Score on Visual Analogue Scale (VAS) for Pain | 3.3 score on a scale | Standard Deviation 1.7 |
| Spinal Anesthesia | Score on Visual Analogue Scale (VAS) for Pain | 2.5 score on a scale | Standard Deviation 1.4 |