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

Pertrochanteric Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693404
• Other study ID #: 18-01019
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: June 5, 2021

Study information

• Verified date: June 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 5, 2021
• Est. primary completion date: June 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pertrochanteric Fracture

Intervention

Drug:
• Marcaine, Duramorph , ketorolac
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)
0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
• General Anesthetics
Placebo group will only receive standard of care general anesthesia

Locations

Country	Name	City	State
United States	New York University Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used	Number of mgs taken of oral morphine	Post-Operative Day 0
Primary	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
Primary	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