NCT03693404

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pertrochanteric Fracture

Interventions

Type	Name	Description
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.
DRUG	Bupivacaine (Marcaine)	0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
DRUG	General Anesthetics	Placebo group will only receive standard of care general anesthesia

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-06-05
• Completion: 2021-06-05
• First posted: 2018-10-03
• Last updated: 2022-07-21
• Results posted: 2022-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study