Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
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|ClinicalTrials.gov Identifier: NCT02160301|
Recruitment Status : Withdrawn (Insufficient infrastructure/funding for enrollment)
First Posted : June 10, 2014
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Pain Control||Drug: Gabapentin Drug: Acetaminophen Drug: Celecoxib Drug: Dexamethasone Drug: Oxycodone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients|
|Estimated Study Start Date :||November 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
Other Name: Neurontin
Other Name: Ofirmev
Other Name: Celebrex
Other Name: Baycadron
Other Name: Roxicodone
Active Comparator: Standard pain control
Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn.
Other Name: Roxicodone
- Pain [ Time Frame: 6 months ]VAS score for pain control, daily for two weeks post op and at all follow up visits for 6 months.
- Narcotic Use [ Time Frame: 2 months ]Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.
- Patient Satisfaction [ Time Frame: 3 months ]Measurement of patient satisfaction with pain control regimen using the American Pain Society's Patient Outcome Questionnaire (APS-POQ).
- Patient function [ Time Frame: 6 months ]Measurement of patient function using the Short Musculoskeletal Functional Assessment questionnaire.
- Fracture Union [ Time Frame: 6 months ]Binary determination of fracture union (yes or no) during the 6 month duration of the study.
- Adverse events [ Time Frame: 6 months ]Measurement of the rate of adverse events post operatively.
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): NCT02160301
|United States, North Carolina|
|UNC Chapel Hill Hospital|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Robert F Ostrum, MD||UNC Chapel Hill|