Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery

Conditions
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Pertrochanteric Fracture

Intervention / Treatment
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* Drug: Marcaine, Duramorph , ketorolac
* Drug: Bupivacaine (Marcaine)
* Drug: General Anesthetics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Anesthesia<br>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: Marcaine, Duramorph , ketorolac<br>* 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.<br>Drug: Bupivacaine (Marcaine)<br>* 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.<br>|
| Active Comparator: General Anesthesia<br>The control group will receive no injection into area surrounding the fracture site | Drug: General Anesthetics<br>* Placebo group will only receive standard of care general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |