Phase 4
N=190
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Pertrochanteric Fracture
Bottom Line
View on ClinicalTrials.gov: NCT03693404 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used — 16; 10 morphine milligram equivalents (MME)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Marcaine, Duramorph , ketorolac (Drug); Bupivacaine (Marcaine) (Drug); General Anesthetics (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used |
16; 10 | — |
| PRIMARY Ambulation Distance |
48.7; 88.9 | — |
| PRIMARY Score on Visual Analogue Scale (VAS) for Pain |
3.3; 2.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03693404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.