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Completed

NCT Number: NCT03693404

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

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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Key information

Conditions

Pertrochanteric Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: Post-Operative Day 0

    Number of mgs taken of oral morphine

  2. Ambulation Distance

    Time frame: 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.

  3. Score on Visual Analogue Scale (VAS) for Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2018
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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