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

Phase 4

Completed

• Conditions: Pertrochanteric Fracture
• Interventions: Drug: Marcaine, Duramorph , ketorolac; Drug: General Anesthetics; Drug: Bupivacaine (Marcaine)

• Registration Number: NCT03693404
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Study Start: 2018-12-01
• Primary Completion: 2021-06-05
• Study Completion: 2021-06-05
• Status Verified: 2022-06
• Results First Submitted: 2022-06-05
• Results First Submitted QC: 2022-06-28
• Last Update Submitted: 2022-06-28
• Results First Posted: 2022-07-21
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Anesthesia	Bupivacaine (Marcaine)	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.
Spinal Anesthesia	Marcaine, Duramorph , ketorolac	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.
General Anesthesia	General Anesthetics	The control group will receive no injection into area surrounding the fracture site

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New York University Langone Health; 🇺🇸 New York, New York, United States