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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Recruitment Status : Withdrawn (Insufficient infrastructure/funding for enrollment)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
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.

Condition or disease Intervention/treatment Phase
Post Operative Pain Control Drug: Gabapentin Drug: Acetaminophen Drug: Celecoxib Drug: Dexamethasone Drug: Oxycodone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Gabapentin
PO
Other Name: Neurontin

Drug: Acetaminophen
PO
Other Names:
  • Tylenol
  • Acephen
  • Cetafen
  • Mapap
  • Q-Pap
  • Valorin

Drug: Acetaminophen
IV
Other Name: Ofirmev

Drug: Celecoxib
PO
Other Name: Celebrex

Drug: Dexamethasone
IV
Other Name: Baycadron

Drug: Oxycodone
PO
Other Name: Roxicodone

Active Comparator: Standard pain control
Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn.
Drug: Acetaminophen
PO
Other Names:
  • Tylenol
  • Acephen
  • Cetafen
  • Mapap
  • Q-Pap
  • Valorin

Drug: Oxycodone
PO
Other Name: Roxicodone




Primary Outcome Measures :
  1. 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.

  2. Narcotic Use [ Time Frame: 2 months ]
    Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.

  3. 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).


Secondary Outcome Measures :
  1. Patient function [ Time Frame: 6 months ]
    Measurement of patient function using the Short Musculoskeletal Functional Assessment questionnaire.

  2. Fracture Union [ Time Frame: 6 months ]
    Binary determination of fracture union (yes or no) during the 6 month duration of the study.

  3. Adverse events [ Time Frame: 6 months ]
    Measurement of the rate of adverse events post operatively.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bone fracture
  • Isolated injury
  • Requires operative intervention

Exclusion Criteria:

  • pathological fractures
  • inability to personally consent to participation due to cognitive impairment, intoxication or sedation
  • severe head injury
  • polytrauma patients with multiple fractures or other injuries
  • pregnancy
  • open fractures
  • metabolic bone disease
  • allergies or contraindications to the study medications, including sulfa medications.
  • prior or current drug or alcohol dependence or abuse
  • liver or kidney disease
  • physician directed narcotic use

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): NCT02160301


Locations
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United States, North Carolina
UNC Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Robert F Ostrum, MD UNC Chapel Hill

Publications:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02160301     History of Changes
Other Study ID Numbers: 13-2669
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

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

Keywords provided by University of North Carolina, Chapel Hill:
pain
postoperative
multimodal
satisfaction
narcotic

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Celecoxib
Acetaminophen
Oxycodone
Gabapentin
BB 1101
Narcotics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics