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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693404
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pertrochanteric Fracture Drug: Marcaine, Duramorph , ketorolac Drug: Bupivacaine (Marcaine) Drug: General Anesthetics Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Spinal Anesthesia
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
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.

Active Comparator: General Anesthesia
The control group will receive no injection into area surrounding the fracture site
Drug: General Anesthetics
Placebo group will only receive standard of care general anesthesia




Primary Outcome Measures :
  1. amount (mg) of narcotics (oral morphine mg equivalents) used [ Time Frame: 6 Months ]
    Number of mgs taken of oral morphine

  2. duration of narcotic use [ Time Frame: 6 Months ]
    Number of days on morphine post surgery

  3. patient reported pain scores using VAS score [ Time Frame: 6 Months ]
    Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693404


Contacts
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Contact: Rivka Ihejirika, MD 646 501 0291 rivka.ihejirika@nyulangone.org

Locations
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United States, New York
New York University Langone Health Recruiting
New York, New York, United States, 10016
Contact: Karan Patel    646-501-0291    karan.patel@nyumc.org   
Principal Investigator: Philip Leucht, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Philipp Leucht, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03693404    
Other Study ID Numbers: 18-01019
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ketorolac
Morphine
Bupivacaine
Anesthetics
Anesthetics, General
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics