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Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02160301
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Detailed Description

Patients will be assessed for inclusion or exclusion during admission to the hospital or during evaluation in the clinic or emergency room for an isolated extremity fracture for which surgery is indicated. Once enrolled in the study and consent obtained, patients will be randomized into either the standard therapy group or the multimodal therapy group using permuted block randomization based on injury site. The sites of fracture are as follows:

  • wrist/hand/forearm

  • elbow/upper arm/shoulder

  • acetabulum/pelvis

  • foot/ankle

  • patella/tibia (shaft, proximal)

  • femur (proximal to distal)

The investigators have assumed that these distinct areas result in a similar amount of disability and pain as compared to the other sites. This is an attempt to mitigate the possible confounder of disproportionate numbers of more painful or more debilitating injuries falling in one study group compared to another.

Pre-operatively, patient demographic data will be recording including age, gender, BMI, hand dominance, occupation, use of tobacco/alcohol/illicit drugs, use of assistive devices, relevant comorbidities (i.e., diabetes), site of injury, mechanism and energy (high or low). If there is to be a delay between initial presentation and surgery, as is often the case for distal radius or ankle fractures, among others, multimodal patients will begin their therapy immediately after evaluation. Thus, they will be started on scheduled 1000mg acetaminophen and 100mg gabapentin both three times daily. They will also be provided an 5mg oxycodone prescription with instructions to take 1-3 tablets every 4 hours as needed for pain. Standard therapy patients will be prescribed oxycodone alone, using the same parameters, with the ability to take acetaminophen on an as needed basis.

Pre-operatively, multimodal patients will receive 1000mg IV acetaminophen, 100mg PO gabapentin and 400mg PO celecoxib. All patients will have a peripheral nerve block placed when indicated, to confirm to the investigators standard of care. Patients will then undergo surgery with the investigators standardized anesthesia protocol as described in the protocol. Intraoperatively, multimodal patients will receive 8mg of IV dexamethasone. Post-operatively, multimodal patients will be given 1000mg acetaminophen three times daily for the duration of their narcotic use and 100mg Gabapentin three times daily for 1 week, which will be titrated to 200mg three times daily for 1 additional week. They will also receive an oxycodone prescription as described previously. Standard therapy patients will be given an oxycodone prescription alone with the advice to take tylenol on an as needed basis not to exceed 4000mg/day. No placebo medications will be used as this is an open label study.

Patients will be instructed to avoid all anti-inflammatory medications. All patients across groups will be given aspirin 81mg for deep vein thrombosis prophylaxis if they suffered a lower extremity fracture. Should a patient require an alternative deep vein thrombosis prophylaxis regimen due to an allergy to aspirin or a personal history of deep vein thromboses, low molecular weight heparin will be used.

Patients will be given a diary to record their daily narcotic use, daily minimum, maximum and average pain scores using a visual analog scale and any side effects. Patients will be provided the contact information of the attending surgeon's nurse to report any serious allergies or adverse effects of the study medications. A case by case decision will be made to either continue the protocol or to drop the patient from the study and make needed medications changes.

Patients will be followed at defined time points after surgery including, 2 wks, 6wks, 3mo and 6mo.

At their 2 wk follow up visit they will fill out the Short Musculoskeletal Function Assessment for their preoperative functional state as well as the American Pain Society Patient Satisfaction Questionnaire. These will again be filled out at their 3 and 6 month visits. Union will be assessed at their 3 and 6 month visits by a third party, blinded observed. It will be defined as three cortices of bridging callus on 2 orthogonal views. Once fracture union occurs or nonunion is identified control patients will be allowed to use non steroidal anti-inflammatories as needed. Time to return to work/normal activity, total narcotic usage and duration of narcotic use will also be recorded.

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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 Names:
  • Neurontin

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

    • Drug: Acetaminophen
    IV
    Other Names:
  • Ofirmev

    • Drug: Celecoxib
    PO
    Other Names:
  • Celebrex

    • Drug: Dexamethasone
    IV
    Other Names:
  • Baycadron

    • Drug: Oxycodone
    PO
    Other Names:
  • 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 Names:
  • Roxicodone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain [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 [2 months]

      Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.

    3. Patient Satisfaction [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 [6 months]

      Measurement of patient function using the Short Musculoskeletal Functional Assessment questionnaire.

    2. Fracture Union [6 months]

      Binary determination of fracture union (yes or no) during the 6 month duration of the study.

    3. Adverse events [6 months]

      Measurement of the rate of adverse events post operatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UNC Chapel Hill Hospital Chapel Hill North Carolina United States 27514

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Robert F Ostrum, MD, UNC Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT02160301
    Other Study ID Numbers:
    • 13-2669
    First Posted:
    Jun 10, 2014
    Last Update Posted:
    May 19, 2017
    Last Verified:
    May 1, 2017
    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:
    Pain, Postoperative
    Acetaminophen
    Dexamethasone
    Celecoxib
    Oxycodone
    Gabapentin

    Study Results

    No Results Posted as of May 19, 2017