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

NYU Langone Health190 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

190

Conditions

Pertrochanteric Fracture

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used

Number of mgs taken of oral morphine

Time frame: 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.

Time frame: 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.

Time frame: Hour 24