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

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Pertrochanteric Fracture

Treatments: Drug: Bupivacaine (Marcaine); Drug: General Anesthetics; Drug: Marcaine, Duramorph , ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT03693404

18-01019

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

190 participants in 2 patient groups

Spinal Anesthesia

Experimental group

Description:

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.

Treatment:

Drug: Marcaine, Duramorph , ketorolac

Drug: Bupivacaine (Marcaine)

General Anesthesia

Active Comparator group

Description:

The control group will receive no injection into area surrounding the fracture site

Treatment:

Drug: General Anesthetics