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

NCT03693404 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-01019
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Pertrochanteric Fracture

Outcome Measures

Primary Outcomes (3)

• Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used

  Number of mgs taken of oral morphine

  Post-Operative Day 0

• 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

• 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

Study Arms (2)

Spinal Anesthesia

EXPERIMENTAL

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: Marcaine, Duramorph , ketorolac; Drug: Bupivacaine (Marcaine)

General Anesthesia

ACTIVE COMPARATOR

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

Drug: General Anesthetics

Interventions

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.

Spinal Anesthesia

Bupivacaine (Marcaine) DRUG

0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.

Spinal Anesthesia

General Anesthetics DRUG

Placebo group will only receive standard of care general anesthesia

General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Ihejirika-Lomedico R, Solasz S, Lorentz N, Egol KA, Leucht P; and NYU Hip Fracture Research Group. Effects of Intraoperative Local Pain Cocktail Injections on Early Function and Patient-Reported Outcomes: A Randomized Controlled Trial. J Orthop Trauma. 2023 Sep 1;37(9):433-439. doi: 10.1097/BOT.0000000000002628.

  PMID: 37199438 DERIVED

MeSH Terms

Interventions

Bupivacaine; Morphine; Ketorolac; Anesthetics, General

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Philipp Leucht, MD
• Organization: NYU Langone Health

philipp.leucht@nyulangone.org

646-501-0291

Study Officials

• Philipp Leucht, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: December 1, 2018
• Primary Completion: June 5, 2021
• Study Completion: June 5, 2021
• Last Updated: July 21, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)