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Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery

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ClinicalTrials.gov Identifier: NCT04018768
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.

Condition or disease Intervention/treatment
Shoulder Pain Other: ibuprofen 600 mg Other: Oxycodone/acetaminophen (Percocet) 5 mg/325

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Group/Cohort Intervention/treatment
Ibuprofen + Percocet Other: ibuprofen 600 mg
MRN ending in an EVEN # will receive ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg for pain that is not adequately controlled by the ibuprofen.

Other: Oxycodone/acetaminophen (Percocet) 5 mg/325
MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.

Percocet Other: Oxycodone/acetaminophen (Percocet) 5 mg/325
MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.




Primary Outcome Measures :
  1. Change in Visual Analog Scale (VAS) Score [ Time Frame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery ]
    Scale consisting of a drawn line from 0 to 100 - the patient will be asked to mark where they believe their pain is (100 being worse pain).

  2. Change in Verbal Rating Scale (VRS) [ Time Frame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery ]
    Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for isolated arthroscopic shoulder instability surgery
Criteria

Inclusion Criteria:

  • ASA class I-II
  • Patients scheduled for arthroscopic shoulder instability surgery

Exclusion Criteria:

  • Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age or older than 65
  • Any patient considered a vulnerable subject
  • Patients on pain medication prior to surgery

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): NCT04018768


Contacts
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Contact: Kamali Thompson (201)-657-0415 kamali.thompson@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Kamali Thompson    201-657-0415    kamali.thompson@nyulangone.org   
Principal Investigator: Kirk Campbell, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Kirk Campbell New York Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04018768     History of Changes
Other Study ID Numbers: 17-01177
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Oxycodone
Narcotics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants