Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedMay 29, 2020
May 1, 2020
1.2 years
May 29, 2019
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Visual Analog Scale (VAS) Score
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).
30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Change in Verbal Rating Scale (VRS)
Consisting of 4 points (0 = no pain, 1 = mild, 2 = moderate, and 3 = severe)
30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Study Arms (2)
Ibuprofen + Percocet
Percocet
Interventions
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.
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.
Eligibility Criteria
Patients indicated for isolated arthroscopic shoulder instability surgery
You may qualify if:
- ASA class I-II
- Patients scheduled for arthroscopic shoulder instability surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Related Publications (1)
Bloom DA, Baron SL, Luthringer TA, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Preoperative Opioid Education has No Effect on Opioid Use in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Clinical Trial. J Am Acad Orthop Surg. 2021 Oct 1;29(19):e961-e968. doi: 10.5435/JAAOS-D-20-00594.
PMID: 33306558DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirk Campbell
New York Langone Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2019
First Posted
July 12, 2019
Study Start
December 1, 2017
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
May 29, 2020
Record last verified: 2020-05