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

NCT ID: NCT04018768

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ibuprofen + Percocet

ibuprofen 600 mg

Intervention Type OTHER

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.

Oxycodone/acetaminophen (Percocet) 5 mg/325

Intervention Type OTHER

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

Oxycodone/acetaminophen (Percocet) 5 mg/325

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirk Campbell

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33306558 (View on PubMed)

Other Identifiers

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17-01177

Identifier Type: -

Identifier Source: org_study_id

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